New FDA Specialty Approvals

✦ Nov. 9: The FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may be appropriate for treatment with AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib). The agency initially approved the liquid biopsy test in August (RSP 9/20, p. 8); it’s now approved as a companion diagnostic for seven targeted therapies across four tumor types. The manufacturer says it is the only FDA-approved blood-based test that can analyze more than 300 genes. Visit https://bit.ly/3gINu3h.

✦ Nov. 13: The FDA gave accelerated approval to Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of people with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test (see brief below). The agency initially approved the programmed death receptor-1 (PD-1) inhibitor in 2014 (RSP 9/14, p. 4); it now has almost 30 approvals across almost 20 types of cancer. This newest approval is its first in breast cancer. Dosing for this indication is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for dosing every three weeks is $9,869.94; for every six weeks, it’s $19,739.88, according to the Keytruda website. Visit www.keytruda.com.

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