New FDA Specialty approvals

May 6: The FDA gave accelerated approval to Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping (METex14) as detected by an FDA-approved test. The agency also approved Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for this use. The recommended dose for the tablet is 400 mg twice daily. The list price for a 28-day supply is $17,950. Visit www.us.tabrecta.com and https://bit.ly/2Sp4MJo.

May 8: The FDA gave accelerated approval to Eli Lilly and Co. subsidiary Loxo Oncology, Inc.’s Retevmo (selpercatinib) to treat adults with metastatic rearranged during transfection fusion-positive NSCLC; people at least 12 years old with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy; and people at least 12 years old with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory. Dosing is weight-based. The drug’s list price is $20,600 for 30 days of treatment. Visit www.retevmo.com.

AIS Health Staff

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