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.

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.

Related Posts

https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Another-Immunotherapy-Indication-Will-Be-Withdrawn.jpg
November 16

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/10/WordPress-Featured-Image_NSCLC.jpg
November 16

New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Specialty-Trend-Increase-Slows-Biosimilars-Are-Having-Impact.jpg
November 16

Prime Therapeutics Launches IntegratedRx – Oncology, Partners on MIP Accreditation

READ MORE

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today