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Monthly News Roundup - October 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 

In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Previously approved under an Emergency Use Authorization (EUA), Veklury is now fully cleared for the treatment of hospitalized patients with COVID-19.

  • Veklury is a nucleotide analog RNA polymerase inhibitor and works by stopping replication of SARS-CoV-2. It is widely available in U.S. hospitals.
  • Veklury is used in adults and children (12 years and older and weighing at least 40 kg) and is given by intravenous (IV) infusion once a day for 5 to 10 days based on patient status.
  • Veklury approval is based on 3 trials including the randomized, double-blind, placebo-controlled ACTT-1 trial which significantly improved time to recovery as compared to placebo (10 vs. 15 days) in the overall population and in patients who required oxygen support at baseline (11 vs. 18 days).
  • The most common side effects (>5%) include nausea and elevated liver enzymes. Rash, allergy and infusion site reactions may also occur.
  • Use of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended.
  • A revised EUA for the unapproved use of Veklury is in effect for hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV) agent is clinically appropriate.

Venclexta + Azacitidine Extends Overall Survival in Older AML Patients

AbbVie and Genentech have been granted full FDA approval for Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of acute myeloid leukemia (AML) in adults 75 years or older, or who have medical conditions that preclude use of intensive induction chemotherapy.

  • Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, was previously granted provisional approval in Nov. 2018. It is also approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Results from Phase III studies showed that Venclexta plus azacitidine significantly reduced the risk of death by 34% compared to azacitidine alone, with a median overall survival of 14.7 months vs. 9.6 months, respectively.
  • Significantly higher rates of complete remission were also seen with the combined treatment (37%) group compared to azacitidine alone (18%).
  • NCCN guidelines recommend Venclexta plus azacitidine as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy.
  • Frequent and serious adverse reactions included low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal; 19%) and bleeding (6%).

FDA Approves Opdivo + Yervoy for Malignant Pleural Mesothelioma

In October, Bristol Myers Squibb announced approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

  • Mesothelioma is a rare but aggressive form of cancer that often forms in the lining of the lungs. In advanced disease, median survival is about one year and the five-year survival rate is roughly 10%.
  • Approval was based on an interim analysis from the Phase 3 CheckMate-743 trial. Opdivo + Yervoy demonstrated significantly better overall survival (OS) versus platinum-based chemotherapy, with a median OS of 18.1 months vs. 14.1 months, respectively. At two years, 41% of patients treated with Opdivo + Yervoy were alive compared to 27% with chemotherapy.
  • Opdivo and Yervoy have serious Warnings and Precautions including severe and possibly fatal immune-mediated reactions in multiple organ systems of the body. Other side effects include infusion reactions, complications of stem-cell transplant, and embryo-fetal toxicity.

Keytruda Use Expanded for Relapsed/Refractory Classical Hodgkin Lymphoma

Keytruda (pembrolizumab) is Merck’s anti-PD-1 immunotherapy with close to two dozen approved cancer indications. Keytruda now has a new expanded use in the treatment of classical Hodgkin Lymphoma as a single agent (monotherapy) for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

  • Hodgkin lymphoma is a type of blood cancer that develops in the white blood cells (lymphocytes) of the immune system.
  • In the Phase 3 KEYNOTE-204 trial, Keytruda significantly reduced the risk of disease progression or death by 35% compared to brentuximab vedotin (Adcetris). Median progression-free survival was 13.2 months for patients treated with Keytruda and 8.3 months for patients treated with brentuximab vedotin.
  • A pediatric indication was also updated for patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.
  • Keytruda can cause severe or life-threatening immune-mediated side effects and infusion-related reactions. Common side effects are upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia (fever), fatigue, rash and cough (20% each).

Inmazeb Now First Approved Treatment Specifically for Ebola Virus

Regeneron Pharmaceuticals has announced clearance for Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) to treat Zaire ebolavirus in adults and children, including newborns of mothers who have tested positive for the infection.

  • Inmazeb is a combination of 3 monoclonal antibodies that bind to proteins on the Ebola virus to help prevent entry into healthy cells. Inmazeb is given as a single, weight-based intravenous infusion.
  • Inmazeb was developed in collaboration with BARDA and is delivered for free in response to outbreaks in the Democratic Republic of the Congo (DRC) via compassionate use. There is also a goal of building national preparedness for public health emergencies.
  • Inmazeb may cause hypersensitivity reactions, including infusion-related events which can be severe or life-threatening. Common adverse events (incidence ≥20%) include pyrexia (fever), chills, tachycardia (rapid heartbeat), tachypnea (rapid breathing), and vomiting, but may be confounded by disease symptoms.

Sklice Lotion Gains Rx-to-OTC Switch for Head Lice Treatment

The FDA has given approval for the nonprescription use of Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice infestation in patients 6 months of age and older.

  • In the U.S., it is estimated that between 6 and 12 million cases of head lice infestation occur each year in children 3 to 11 years of age. The prescription version of the single-use Sklice was first available in 2012.
  • Sklice is used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.
  • Arbor Pharmaceuticals was granted approval for the OTC version of Sklice. The prescription product will no longer be available.

Posted: October 2020