New FDA Specialty Approvals

Feb. 3: The FDA gave accelerated approval to Merck KGaA unit EMD Serono, Inc.’s Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. The agency gave the drug priority review and breakthrough therapy and orphan drug designations. The therapy was approved under the FDA’s Real-Time Oncology Review pilot program. Dosing for the tablet is 450 mg via two 225 mg tablets once daily. The list price of a 30-day supply is $20,898. Visit www.tepmetko.com.

Feb. 5: The FDA approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. The agency gave the CD19-directed chimeric antigen receptor T cell (CAR-T) therapy orphan drug, regenerative medicine advanced therapy and breakthrough therapy designations. The list price for the one-time treatment is $410,300. Visit www.breyanzi.com.

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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