New FDA Specialty Approvals

✦ April 8: The FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test (see brief below), after prior therapy. The agency initially approved the capsule in June 2018 (RSP 7/18, p. 10). The recommended dose for the new use is 300 mg once daily in combination with Erbitux. Website GoodRx lists the price of two bottles, each with 90 75 mg capsules, as more than $12,400. Visit www.braftovi.com.

✦ April 13: The FDA approved AstraZeneca and Merck & Co., Inc.’s Koselugo (selumetinib) for people at least 2 years old with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The agency gave the kinase inhibitor breakthrough therapy, rare pediatric disease and orphan drug designations. AstraZeneca received a priority review voucher under the rare pediatric disease designation program. Recommended dosage of the capsule is 25 mg/m2 twice daily. Multiple news outlets report that the drug’s monthly list price for an average patient will be $12,500. Visit www.koselugo.com.

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