An experimental breast cancer therapy treatment from Pfizer (NYSE:PFE) has been given the Food and Drug Administration’s ‘breakthrough therapy designation.’ This recognition of the new drug could help expedite development on this drug.
This designation was awarded as a result of data that was presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium. At the Symposium, the company presented findings that the women who were treated with a combination of letrozole and palbociclib achieved significant progress compared to the women who took letrozole alone.
Patients who were treated with a combination of drugs “went more than 26 months without worsening symptoms, as opposed to 7.5 months for patients only using letrozole.” The drug will go into testing for Phase III.
Dr. Mace Rothenberg of Pfizer’s Oncology business unit said that ““We appreciate the opportunity that Breakthrough Therapy designation provides to work closely with the FDA on the development of palbociclib.” The company is looking at the drug as a definite advancement for treating cancer.
According to Reuters, analysts from JP Morgan and Leerink Swan say that this oral medicine could generate annual sales of $5 billion or more if the drug is approved for the treatment of breast cancer.
The new designation, which the drug has been granted, is intended to help development of drugs that could assist in treating life-threatening diseases. The designation was created as part of the 2012 FDA Safety and Innovation Act (FDASIA).