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.