New FDA Specialty Approvals

July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kinase inhibitor (TKI) therapies for non-small cell lung cancer (NSCLC) targeting EGFR and KRAS wild-type tumor tissue for metastatic colorectal cancer patients. The in vitro diagnostic kit is intended to be used on the Illumina MiSeq Dx instrument.

Aug. 2: The FDA approved Astra-Zeneca’s Saphnelo (anifrolumab-fnia) to treat adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. It is the first type I interferon (type I IFN) receptor antagonist to gain FDA approval and the first product approved for the most common form of lupus in more than 10 years. The recommended dose is 300 mg via a 30-minute intravenous infusion every four weeks. Drugs.com lists the price of one 100 mg vial as more than $1,799.00.

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.

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