Pfizer Inc. has completed the rolling NDA submission for its high-profile breast cancer treatment palbociclib, positioning the drug for a potential approval in the first half of 2015 – but it remains to be seen whether FDA grants an accelerated approval based on limited Phase II data in a relatively well-served setting.
Pfizer announced it completed the filing Aug. 18. The company is seeking approval of palbociclib in combination with the aromatase inhibitor letrozole (Femara and generics) for the treatment of postmenopausal...