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US FDA’s Latest Breakthrough Therapy Awards Include Asthma, Alopecia Areata, And (Of Course) Oncology Therapies

Executive Summary

New 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.

Concert Says Phase II Alopecia Drug Could Beat Pfizer’s Candidate To Market

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.

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