Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data
This article was originally published in The Pink Sheet Daily
Pfizer finished a rolling NDA for the high-profile breast cancer drug, the first-in-class CDK-4/6 inhibitor. Whether or not 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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The CDK 4/6 inhibitor Ibrance (palbocliclib) just got its first approval in first-line metastatic breast cancer and Pfizer is losing no time on development, with trials of other indications planned or ongoing, including different tumor types.
Global Innovative Pharma Business President Geno Germano sat down with “The Pink Sheet” to discuss growth strategy, M&A and Pfizer’s increasing focus on value in a changing health care world.
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.