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Pfizer Breast Cancer Drug Could Fill Void Left By Avastin Withdrawal

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data

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.

Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data

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.

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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