New Indications & Dosage Forms for Existing Drugs

Bavencio (avelumab) Injection

New Indication Approved: June 30, 2020
Date of Original Approval: March 23, 2017

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

• FDA Approves Bavencio as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
• Bavencio approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 29, 2020
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, and cutaneous squamous cell carcinoma.

• FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
• Keytruda approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 24, 2020
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, and cutaneous squamous cell carcinoma.

• FDA Approves Merck’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation
• Keytruda approval history

Xpovio (selinexor) Tablets

New Indication Approved: June 22, 2020
Date of Original Approval: July 3, 2019

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

• Karyopharm Announces FDA Approval of Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
• Xpovio approval history

Crysvita (burosumab-twza) Injection

New Indication Approved: June 18, 2020
Date of Original Approval: April 17, 2018

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH) and FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO).

• Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)
• Crysvita approval history

Tazverik (tazemetostat) Tablets

New Indication Approved: June 18, 2020
Date of Original Approval: January 23, 2020

Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of:

• adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
• Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
• Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• Epizyme Announces U.S. FDA Accelerated Approval of Tazverik (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
• Tazverik approval history

Dupixent (dupilumab) Injection

New Dosage Form Approved: June 18, 2020
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

• for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
• as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus.
• as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

• FDA Approves New Dupixent (dupilumab) Pre-Filled Pen Designed to Support More Convenient Self-Administration
• Dupixent approval history

Cosentyx (secukinumab) Injection

New Indication Approved: June 16, 2020
Date of Original Approval: January 21, 2015

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

• Cosentyx Receives FDA Approval for New Indication to Treat Active Non-Radiographic Axial Spondyloarthritis
• Cosentyx approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 16, 2020
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, and cutaneous squamous cell carcinoma.

• FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type
• Keytruda approval history

Ilaris (canakinumab) Injection

New Indication Approved: June 16, 2020
Date of Original Approval: June 17, 2009

Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever), and active Still’s disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).

• Ilaris (canakinumab) Receives FDA Approval for New Indication to Treat Adult-Onset Still’s Disease (AOSD)
• Ilaris approval history

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection

New Indication Approved: June 12, 2020
Date of Original Approval: December 10, 2014

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine indicated for use in:

• girls and women 9 through 45 years of age for the prevention of:
  • cervical, vulvar, vaginal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
  • genital warts (condyloma acuminata) caused by HPV types 6 and 11
  • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
• boys and men 9 through 45 years for the prevention of:
  • anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
  • genital warts (condyloma acuminata) caused by HPV types 6 and 11
  • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

• FDA Approves Merck’s Gardasil 9 for the Prevention of Certain HPV-Related Head and Neck Cancers
• Gardasil 9 approval history

Tivicay (dolutegravir) Tablets

New Dosage Form Approved: June 12, 2020
Date of Original Approval: August 12, 2013

Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.

• FDA Approves Tivicay PD (dolutegravir) Once-Daily Dispersible Tablet Formulation for Children with HIV
• Tivicay approval history

Opdivo (nivolumab) Injection

New Indication Approved: June 10, 2020
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

• FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy
• Opdivo approval history

Recarbrio (imipenem, cilastatin, and relebactam) for Injection

New Indication Approved: June 4, 2020
Date of Original Approval: July 16, 2019

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

• FDA Approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
• Recarbrio approval history

Tecentriq (atezolizumab) Injection

New Indication Approved: May 29, 2020
Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and heptatocellular carcinoma.

• FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With Hepatocellular Carcinoma
• Tecentriq approval history

Cyramza (ramucirumab) Injection

New Indication Approved: May 29, 2020
Date of Original Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

• as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
• in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
• in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
• in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
• as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

• Lilly's Cyramza (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
• Cyramza approval history

Taltz (ixekizumab) Injection

New Indication Approved: May 29, 2020
Date of Original Approval: March 22, 2016

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of:

• patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• adults with active psoriatic arthritis.
• adults with active ankylosing spondylitis.
• adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

• Lilly's Taltz (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
• Taltz approval history

Brilinta (ticagrelor) Tablets

New Indication Approved: May 28, 2020
Date of Original Approval: July 20, 2011

Brilinta (ticagrelor) is a P2Y₁₂ platelet inhibitor indicated:

• to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
  Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
• to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).

• Brilinta Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease
• Brilinta approval history

Sirturo (bedaquiline) Tablets

New Formulation Approved: May 27, 2020
Date of Original Approval: December 28, 2012

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

• FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
• Sirturo approval history

VESIcare (solifenacin succinate) Tablets

New Dosage Form Approved: May 26, 2020
Date of Original Approval: November 19, 2004

VESIcare (solifenacin) is a muscarinic receptor antagonist for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
VESIcare LS is an oral suspension formulation of solifenacin for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.

• FDA Approves VESIcare LS (solifenacin succinate) Oral Suspension for Neurogenic Detrusor Overactivity (NDO) Pediatric Patients
• VESIcare approval history

Dupixent (dupilumab) Injection

Patient Population Altered: May 26, 2020
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

• for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
• as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus.
• as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

• FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis
• Dupixent approval history

Opdivo (nivolumab) Injection

New Indication Approved: May 26, 2020
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer
• Opdivo approval history

Alunbrig (brigatinib) Tablets

New Indication Approved: May 22, 2020
Date of Original Approval: April 28, 2017

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

• FDA Approves Takeda’s Alunbrig (brigatinib) as a First-Line Treatment Option for Patients with ALK+ Metastatic Non-Small Cell Lung Cancer (NSCLC)
• Alunbrig approval history

Lynparza (olaparib) Tablets

New Indication Approved: May 19, 2020
Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

• Lynparza Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
• Lynparza approval history

Ferriprox (deferiprone) Tablets and Oral Solution

New Formulation Approved: May 19, 2020
Date of Original Approval: October 14, 2011

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

• Chiesi Group Receives FDA Approval for Ferriprox (deferiprone) Twice-a-Day Tablets
• Ferriprox approval history

Tecentriq (atezolizumab) Injection

New Indication Approved: May 18, 2020
Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and heptatocellular carcinoma.

• FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
• Tecentriq approval history

Rubraca (rucaparib) Tablets

New Indication Approved: May 15, 2020
Date of Original Approval: December 19, 2016

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer and prostate cancer.

• Rubraca (rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Rubraca approval history

Opdivo (nivolumab) Injection

New Indication Approved: May 15, 2020
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%
• Opdivo approval history

Pomalyst (pomalidomide) Capsules

New Indication Approved: May 14, 2020
Date of Original Approval: February 8, 2013

Pomalyst (pomalidomide) is a thalidomide analogue indicated for the treatment of patients with multiple myeloma and AIDS-related and HIV-negative Kaposi sarcoma.

• U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
• Pomalyst approval history

Lynparza (olaparib) Tablets

New Indication Approved: May 8, 2020
Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

• Lynparza (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
• Lynparza approval history

Farxiga (dapagliflozin) Tablets

New Indication Approved: May 5, 2020
Date of Original Approval: January 8, 2014

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus and heart failure.

• Farxiga Approved in the US for the Treatment of Heart Failure in Patients with Heart Failure with Reduced Ejection Fraction
• Farxiga approval history

Zejula (niraparib) Capsules

New Indication Approved: April 29, 2020
Date of Original Approval: March 27, 2017

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer.

• FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status
• Zejula approval history

Keytruda (pembrolizumab) for Injection

New Dosage Regimen: April 28, 2020
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, and cutaneous squamous cell carcinoma.

• FDA Approves Merck’s Keytruda (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications
• Keytruda approval history

Jublia (efinaconazole) Topical Solution

Patient Population Altered: April 26, 2020
Date of Original Approval: June 6, 2014

Jublia (efinaconazole) is a topical triazole antifungal for the treatment of onychomycosis of the toenails.

• FDA Approves Ortho Dermatologics' Labeling for Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old
• Jublia approval history

Imbruvica (ibrutinib) Capsules and Tablets

New Indication Approved: April 21, 2020
Date of Original Approval: November 13, 2013

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
• Waldenström’s macroglobulinemia (WM).
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

• FDA Approves Imbruvica (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
• Imbruvica approval history

Braftovi (encorafenib) Capsules

New Indication Approved: April 8, 2020
Date of Original Approval: June 27, 2018

Braftovi (encorafenib) is a kinase inhibitor indicated:

• in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
• in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

• FDA Approves Braftovi (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
• Braftovi approval history

Reblozyl (luspatercept-aamt) for Injection

New Indication Approved: April 3, 2020
Date of Original Approval: November 8, 2019

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for the treatment of:

• Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
• Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
• Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

• FDA Approves Reblozyl (luspatercept-aamt) to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)
• Reblozyl approval history

Imfinzi (durvalumab) Injection

New Indication Approved: March 30, 2020
Date of Original Approval: May 1, 2017

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

• for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
  • have disease progression during or following platinum-containing chemotherapy.
  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.
  This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
• for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
• in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

• Imfinzi (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer
• Imfinzi approval history

Triferic (ferric pyrophosphate citrate)

New Dosage Form Approved: March 27, 2020
Date of Original Approval: January 23, 2015

Triferic (ferric pyrophosphate citrate) is an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

• FDA Approves Triferic AVNU (ferric pyrophosphate citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients
• Triferic approval history

Taltz (ixekizumab) Injection

Patient Population Altered: March 26, 2020
Date of Original Approval: March 22, 2016

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of:

• patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• adults with active psoriatic arthritis.
• adults with active ankylosing spondylitis.
• adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

• Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
• Taltz approval history

Eucrisa (crisaborole) Topical Ointment

Patient Population Altered: March 23, 2020
Date of Original Approval: December 14, 2016

Eucrisa (crisaborole) is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

• FDA Approves Eucrisa (crisaborole) Ointment 2% in Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis
• Eucrisa approval history

Epclusa (sofosbuvir and velpatasvir) Tablets

Patient Population Altered: March 19, 2020
Date of Original Approval: June 28, 2016

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

• FDA Approves Epclusa (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection
• Epclusa approval history

Ofev (nintedanib) Capsules

New Indication Approved: March 9, 2020
Date of Original Approval: October 15, 2014

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated for:

• treatment of idiopathic pulmonary fibrosis (IPF).
• treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
• slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

• FDA Approves Ofev (nintedanib) as First Treatment for Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype
• Ofev approval history

Nerlynx (neratinib) Tablets

New Indication Approved: February 25, 2020
Date of Original Approval: July 17, 2017

Nerlynx (neratinib) is a tyrosine kinase inhibitor indicated:

• as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
• in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

• Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
• Nerlynx approval history

Procysbi (cysteamine bitartrate) Delayed-Release Capsules

New Dosage Form Approved: February 14, 2020
Date of Original Approval: April 30, 2013

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

• Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral Granules
• Procysbi approval history

Voltaren Gel (diclofenac sodium) Topical Gel

Labeling Revision Approved: February 14, 2020
Date of Original Approval: October 17, 2007

Voltaren Gel (diclofenac sodium) is a topical non-steroidal anti-inflammatory (NSAID) medication indicated for the temporary relief of joint pain due to osteoarthritis.

• FDA Approves GSK’s Voltaren Arthritis Pain for Over-the-Counter Use in the United States
• Voltaren Gel approval history

Ajovy (fremanezumab-vfrm) Injection

New Dosage Form Approved: January 27, 2020
Date of Original Approval: September 14, 2018

Ajovy (fremanezumab) is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand indicated for the preventive treatment of migraine.

• Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector
• Ajovy approval history

Dificid (fidaxomicin)

Patient Population Altered: January 24, 2020
Date of Original Approval: May 27, 2011

Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridioides difficile -associated diarrhea.

• FDA Approves Merck’s Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older
• Dificid approval history

Ozempic (semaglutide) Injection

New Indication Approved: January 16, 2020
Date of Original Approval: December 5, 2017

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

• FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease
• Ozempic approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: January 8, 2020
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, and cutaneous squamous cell carcinoma.

• FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
• Keytruda approval history