Pfizer Seeks Early FDA Approval For Breast Cancer Drug

Pharmaceutical giant Pfizer is in the process of acquiring early FDA approval for the company’s experimental breast cancer drug palbociclib. Pfizer is reportedly going to file their application for FDA approval of their breast cancer drug in the third quarter of this year.

The drug giant has been in talks with the FDA about the drug for the past few months. After palbociclib’s successful midstage trial, experts believe that the drug’s development and progression to the market could be accelerated. The results of the drug’s trial were undoubtedly successful, as patients who were treated with palbociclib plus the hormone drug letrozole survived for nearly twice as long as those taking letrozole — 20.2 months to 10.2 months respectively.

Palbociclib has already been designated as a breakthrough therapy by the FDA. That designation allowed for an accelerated testing and approval process, which could help the company avoid having to carry out the larger, more costly late-stage patient studies to apply for palbociclib approval in the future.

Pfizer has been making headlines lately for its attempts to buy rival multinational pharmaceutical company AstraZeneca. Pfizer has already made a $106 billion offer, which was rejected. It has been reported that Pfizer has plans to improve the terms of that offer. Industry analysts believe that Pfizer is attempting to acquire AstraZeneca in an attempt to boost its drug pipeline.

However, palbociclib is one of the few upcoming Pfizer drugs that experts believe could become extremely successful financially. Dr. Timothy Anderson, who works as an industry analyst for BersteinResearch, speculated on how the news could impact Pfizer’s shares. “We currently forecast a launch of palbociclib in 2015 with sales reaching $1.9 (billion) in 2020,” he said. Anderson also went on to say that Eli Lilly and Novartis AG were developing similar breast cancer drugs that could also be promising treatment options.