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.

AIS Health Staff

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