Today, Pfizer Inc. announced that it is in discussion with the US Food and Drug Administration (FDA), regarding its potential blockbuster breast cancer drug palbociclib.
According to the company, it expects to get a final decision from the agency by April 13. Pfizer said that the FDA is not requiring a meeting of its Oncologic Drugs Advisory Committee to discuss Ibrance (palbociclib) prior to an approval decision. Analysts have said that the agency’s move to not require an advisory meeting may be good news for the company. Following the announcement, Pfizer’s shares rose two percent.
The company reported that it has entered label discussions with the FDA and hopes to bring the drug to patients who need it as soon as possible.
In April 2013, palbociclib received FDA breakthrough therapy designation and was accepted for filing and granted priority review from the agency in last October. The decision to grant the drug priority review is based in part on the final results of the Phase II PALOMA-1 trial, which includes patients with ER-positive, HER-2-negative advanced breast cancer. In the Phase II trial, treatment with palbociclib nearly doubled the median progression-free survival (PFS), with patients treated with palbociclib in combination with letrozole demonstrating a median PFS of 20.2 months compared to a median PFS of 10.2 months in patients receiving letrozole alone.
The drug is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation. Loss of cell cycle control is a hallmark of cancer and CDK 4/6 are overactivated in several cancers. The drug is seen as a key asset in Pfizer’s pipeline, which could generate $4 billion in sales in 2020, according to estimates from J.P. Morgan.
Source: Pfizer, Inc.