Pfizer’s Latest Palbociclib Data Could Mean Slimmer Lead Over CDK4/6 Rivals
Final Phase II data for palbociclib in breast cancer at AACR meeting raise questions about prospects for accelerated approval prior to Phase III results. Meanwhile, Lilly’s bemaciclib emerges as potent monotherapy with seemingly lower risk for neutropenia, but more data are needed to flesh out the drug’s profile.
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The latest drug development news and highlights from our FDA Performance Tracker.
Combo trials with Opdivo and Keytruda may help Lilly accelerate its move into cancer immunotherapy. Heading out of its patent cliff, the pharma is focused mainly on cancer, diabetes and neurology.
Pfizer finished a rolling NDA for the high-profile breast cancer drug, the first-in-class CDK-4/6 inhibitor. Whether FDA will agree Phase II data results from the PALOMA-1 trial are sufficient to grant accelerated approval remains to be seen.