Keeping Track: Quick Trips From Breakthrough Designation To Market
Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.
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The latest oncology news and highlights from the Pink Sheet’s FDA Performance Tracker.
The MET inhibitor already pending US FDA approval had good results in patients with brain metastases. Spectrum’s TKI inhibitor poziotinib continues to be studied after Cohort 1 failure.
Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.