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.

AIS Health Staff

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