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Monthly News Roundup - January 2021

FDA Approves ViiV’s Cabenuva, the First Once-a-Month HIV Treatment 

The U.S. Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) as a once-monthly, injectable complete regimen for the treatment of HIV-1 infection in adults. Cabenuva is co-package as two extended-release intramuscular (IM) injectable suspensions: cabotegravir, an integrase strand transfer inhibitor (INSTI) and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

  • Eligible patients should be on a stable regimen and virologically suppressed (HIV-1 RNA <50 copies/mL) with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.
  • Prior to starting treatment, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability.
    Cabenuva is then dosed once monthly to replace the current antiretroviral regimen. Cabenuva is expected to be commercially available in February 2021.
  • In pivotal studies, Cabenuva was as effective in maintaining viral suppression when injected IM in the buttocks every 4 weeks as continuing a daily oral three-drug regimen.
  • Common side effects (>2%) include injection site reactions, fever, fatigue, headache, muscle pain, nausea, sleep disorders, dizziness, and rash.

ViiV’s Vocabria Cleared for Short-Term Oral HIV Treatment

This past month the FDA approved Vocabria (cabotegravir) 30 mg tablets, used in combination with Edurant (rilpivirine) 25 mg tablets for the short-term oral treatment of HIV-1 infection in adults to replace their current HIV-1 medicines. It is not known if Vocabria is safe and effective in children.

  • Vocabria + Edurant is indicated for patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
  • Patients will receive Vocabria + Edurant for one month (at least 28 days) before they receive Cabenuva (cabotegravir and rilpivirine) extended-release intramuscular suspension for the first time. This will allow the healthcare provider to assess how well cabotegravir is tolerated. Vocabria can also be used as oral therapy for people who will miss planned injections with Cabenuva.
  • The most common side effects with Vocabria include: headache, nausea, abnormal dreams, anxiety and sleep disorders. 

Merck’s Verquvo: A First-in-Class Agent for Heart Failure Use

Verquvo (vericiguat) is a once-daily oral soluble guanylate cyclase (sGC) stimulator now approved by the FDA to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

  • Verquvo, from Merck, is the first soluble guanylate cyclase stimulator approved to treat heart failure. sGC is an important enzyme in the nitric oxide (NO) signaling pathway. By directly stimulating sGC, Verquvo increases intracellular cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation and vasodilation.
  • Approval was based on the VICTORIA trial with 5,050 patients that demonstrated that Verquvo was superior to placebo, when used with other heart failure treatments, in reducing the risk of death or hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event.
  • Verquvo tablets are taken orally once daily with food. It is available in 2.5 mg, 5 mg, and 10 mg strengths.
  • Verquvo should not be used by pregnant females as it may cause fetal harm, as noted in the Boxed Warning. Do not use Verquvo with other soluble guanylate cyclase (sGC) stimulators.
  • Common side effects were hypotension (low blood pressure) and anemia (a low number of red blood cells) with rates similar to placebo. Concomitant use of Verquvo with PDE-5 inhibitors is not recommended because of the potential for hypotension.

Lupkynis: The First Oral Therapy Approved for Lupus Nephritis

Lupus nephritis (LN) is a common and serious outcome of systemic lupus erythematosus (SLE), an autoimmune disease. LN can lead to permanent kidney damage or kidney failure, heart complications, and death.

  • In response, the FDA has now approved Lupkynis (voclosporin), a calcineurin-inhibitor immunosuppressant used in combination with an immunosuppressive regimen for the treatment of adult patients with active lupus nephritis (LN). Lupkynis is from Aurinia Pharmaceuticals.
  • In phase 2 and 3 clinical studies up to 52 weeks in length, Lupkynis treatment significantly improved outcomes for patients when added to the standard-of-care (SoC), mycophenolate mofetil (MMF), and low dose steroids. Lupkynis plus SoC was more than two times as effective at achieving a complete renal response and led to a decline in urine protein creatinine ratio (UPCR) twice as fast than the SoC alone.
  • Lupkynis is available as a 7.9 mg oral capsule and the recommended starting dose is 23.7 mg orally every 12 hours on an empty stomach. Modify doses based on kidney and liver function as outlined in the label.
  • Lupkynis carries a Boxed Warning for malignancies and serious infections. Common side effects (>3%) include reduction in glomerular filtration rate, high blood pressure, diarrhea, headache, anemia, and cough, among others.

Opdivo + Cabometyx Cleared as First-Line Treatment for Advanced Kidney Cancer

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for roughly 15,000 deaths in the U.S. annually. This month, Bristol Myers Squibb announced FDA approval of Opdivo (nivolumab) + Cabometyx (cabozantinib) for the first-line treatment of patients with advanced renal cell carcinoma. Since Dec. 2014, Opdivo has received at least 22 approvals in 11 different cancer types.

  • Approval was based on the open label Phase 3 CheckMate -9ER trial, which compared Opdivo in combination with Cabometyx versus sunitinib (Sutent) in patients with advanced RCC. Patients in the Opdivo group lived twice as long without disease progression as those in the sunitinib group (16.6 vs. 8.3 months, respectively). Opdivo + Cabometyx reduced the risk of death by 40% compared to sunitinib.
  • Common side effects included diarrhea (64%), fatigue (51%), and liver toxicity (44%), among many others.
  • Opdivo has also been previously approved in combination with ipilimumab (Yervoy) as first-line treatment for intermediate- and poor-risk advanced renal cell carcinoma and for previously treated advanced (metastatic) renal cell carcinoma.

Xalkori OK’d for ALK-Positive Anaplastic Large Cell Lymphoma in Children, Young Adults

Anaplastic large cell lymphoma (ALCL) is a rare form of non-Hodgkin lymphoma (NHL), a type of lymph cancer, and accounts for approximately 30% of cases of NHL in young people. It develops when T-cells, a type of white blood cell that fights infection, become abnormal. About 90% of ALCL cases in young people are ALK-positive. 

  • Xalkori (crizotinib), an oral anaplastic lymphoma kinase (ALK) inhibitor from Pfizer, is now indicated for the treatment of children and young adults one year of age and older with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Use in older adults has not been established.
  • Approval was based on a single arm, open-label study in 121 patients between the ages of 1 and 21 years. This included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment.
  • Treatment with Xalkori resulted in an objective response rate of 88%. Among the 23 patients who achieved a response, 39% maintained their response for at least 6 months and 22% maintained their response for at least 12 months.
  • Common side effects in the study (≥35%) included diarrhea, vomiting, nausea, vision disorder, headache, and musculoskeletal pain, among others.

Posted: January 2021

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