New FDA Approvals: FDA Grants Additional Approval to Verzenio | Nov. 16, 2021

  • Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.

    Oct. 13: The FDA gave another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of people with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1) (Combined Positive Score (CPS) > 1) as determined by an FDA-approved test. The agency also converted the June 12, 2018, accelerated approval for the programmed death receptor-1 (PD-1) inhibitor for the treatment of people with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS > 1), as determined by an FDA-approved test, to regular approval. The FDA first approved the drug on Sept. 4, 2014. Dosing for both indications is 200 mg via a 30-minute intravenous infusion every three weeks or 400 mg every six weeks. The price of the every-three-weeks dose is $10,067.36; for the every-six-weeks dose, it’s $20,134.72.

    Oct. 15: The FDA gave Boehringer Ingelheim Pharmaceuticals, Inc.’s biosimilar Cyltezo (adalimumab-adbm) interchangeable status for all the indications it’s approved for: moderately to severely active rheumatoid arthritis in adults, juvenile idiopathic arthritis in people at least 2 years old, Crohn’s disease in people at least 6 years old and ulcerative colitis in adults; active psoriatic arthritis and ankylosing spondylitis in adults; and moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. It is the first approved biosimilar of AbbVie Inc.’s Humira (adalimumab) to which the agency has given interchangeable status. Dosing varies across the indications. Website Drugs.com lists the price of two Humira 40 mg/0.4 mL pens as approximately $6,000. The drug is cleared to launch July 1, 2023, per a deal between the two manufacturers.

    Oct. 15: The FDA gave another approval to Roche Group company Genentech USA, Inc.’s Tecentriq (atezolizumab) for the adjuvant treatment, following surgery and platinum-based chemotherapy, of adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1>1%, as determined by an FDA-approved test (see brief below). The review was conducted under the FDA’s Project Orbis initiative and the Real-Time Oncology Review pilot program. The FDA initially approved the PD-L1 inhibitor on May 18, 2016. Following resection and up to four cycles of platinum-based chemotherapy, dosing is 840 mg every two weeks, 1,200 mg every three weeks or 1,680 mg every four weeks for up to one year. The initial dose of the intravenous infusion is 60 minutes; if that is tolerated, subsequent doses may be decreased to 30 minutes. According to Drugs.com, treatment is around $13,860.00 per month depending on the dosing schedule.

    Oct. 18: The FDA expanded the label of Gilead Sciences, Inc.’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) as a lower-dose tablet for the treatment of HIV in pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The agency first approved the drug on Feb. 7, 2018. Dosing is one tablet daily. The list price is $3,394.00 per month.

    Oct. 19: The FDA approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide in 2.5 mg and 20 mg strengths for three indications: the treatment of adults with (1) multiple myeloma in combination with dexamethasone, (2) multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplantation, and (3) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities. The agency also gave tentative approval for 5 mg, 10 mg, 15 mg and 25 mg strengths. The capsule is the first generic approved for Bristol Myers Squibb unit Celgene Corp.’s Revlimid, and Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for the 2.5 mg and 20 mg strengths. Per an agreement with Celgene, the company can begin selling volume-limited amounts on a confidential date after March 2022; beginning Jan. 31, 2026, Dr. Reddy’s can sell the drug without volume limitation. Dosing varies by indication.

    Oct. 20: The FDA expanded the label of Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) to include its use as an add-on maintenance treatment for people between 6 and 11 years old with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The agency first approved the subcutaneous injectable on March 28, 2017. Dosing for people weighing 15 kg to less than 30 kg is 100 mg every other week or 300 mg every four weeks; for those more than 30 kg, it’s 200 mg every other week. A carton of two prefilled syringes or pens costs $3,203.39.

    Oct. 22: The FDA gave another indication to Roche’s Ventana PD-L1 (SP263) Assay as a companion diagnostic to identify certain NSCLC patients eligible for Tecentriq monotherapy for its newest indication, approved Oct. 15 (see above brief). The agency initially approved the test on May 1, 2017.

    Oct. 22: The FDA approved Genentech’s Susvimo (ranibizumab) for the treatment of people with wet, or neovascular, age-related macular degeneration who have responded to at least two anti-vascular endothelial growth factor injections. The product, previously called Port Delivery System with ranibizumab, is for intravitreal use via an ocular implant that is surgically inserted into the eye during a one-time, outpatient procedure and is refilled every six months. The recommended dose is 2 mg continuously delivered through the implant. The cost of the implant and medicine for the first year is $17,250, and each refill is $8,000. The company says the product will be available in the coming months.

    Oct. 29: The FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of chronic myeloid leukemia in two indications: (1) accelerated approval for adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors, and (2) full approval for adults with PH+ CML-CP with the T315I mutation. It is the first FDA-approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor. Recommended dosing for the first indication of the tablet is 80 mg once daily or 40 mg twice daily; for the second, it’s 200 mg twice daily.

  • Angela Maas

    Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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