RADAR on Specialty Pharmacy
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News Briefs: Oncopeptides AB is withdrawing Pepaxto from the U.S. market | Nov. 16, 2021
Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.”
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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.
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Prime Therapeutics Launches IntegratedRx - Oncology, Partners on MIP Accreditation
Many people fighting cancer must get their oral oncolytics from a central fill specialty pharmacy, which can add to the time it takes for a prescription to be filled, as well as potential waste when an oncologist changes a medication. Prime Therapeutics LLC recently unveiled a new program known as IntegratedRx - Oncology that the PBM says will help coordinate care for members and streamline the treatment process.
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New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option
On Oct. 1, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people 18 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). According to a Zitter Insights survey, oncologists said they are likely to prescribe the drug over certain therapies for that indication. Industry experts tell AIS Health, a division of MMIT, that the agent may be a game changer for certain patients, as it fills a treatment gap.
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FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches
Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.
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