Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data
This article was originally published in Pharmaceutical Approvals Monthly
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.
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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.
Pfizer’s novel oral CDK 4/6 inhibitor PD-03392991, in combination with letrozole, delivered a statistically and clinically significant increase in median progression-free survival for women with advanced ER+/HER2- breast cancer, according to interim Phase II data presented Dec. 5 at the San Antonio Breast Cancer Symposium.
FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.