US FDA’s Latest Breakthrough Therapy Awards Include Asthma, Alopecia Areata, And (Of Course) Oncology Therapies
Executive SummaryNew BTDs include Loxo’s RET inhibitor for RET fusion-positive lung cancer and RET mutant medullary thyroid cancer, Y-mAbs’ naxitamab for high-risk neuroblastoma, AstraZeneca/Amgen’s tezepelumab for severe asthma, and Pfizer’s JAK3 inhibitor for alopecia areata.
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The company reported positive Phase III response rate data weeks after strong results in lung cancer for the RET inhibitor also known as LOXO-292. An NDA submission is on track for later this year.
While Pfizer’s JAK3 inhibitor is in Phase II/III for alopecia areata, Concert thinks its deuterium-modified ruxolitinib may get to market sooner. However, the breadth of Incyte’s ruxolinitib patent protection is unclear.
Keeping Track: Pfizer’s Talzenna Ensures Record Year For Novel US Approvals; Novartis Submits SMA Gene Therapy
The latest drug development news and highlights from our FDA Performance Tracker.