New FDA Specialty Approvals

Aug. 5: The FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunotherapy agent. The agency granted the first-in-class anti-B-cell maturation antigen (anti-BCMA)-directed antibody priority review, as well as orphan drug and breakthrough therapy designations. The review was via the Real-Time Oncology Review. Recommended dosing is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every three weeks. The price per 100 mg single-dose vial is $8,277; based on a patient weight of 175 pounds, the monthly treatment cost would be $23,900. Visit www.blenrep.com.

Aug. 7: The FDA approved Guardant Health, Inc.’s Guardant360 CDx for tumor mutation profiling in people with any solid malignant neoplasm. The agency also approved the test as a companion diagnostic to identify people with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with AstraZeneca’s Tagrisso (osimertinib). Visit https://guardant360.com.

Angela Maas

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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