Pfizer's breast cancer treatment gets Breakthrough Therapy status
The promising substance is called palbociclib (PD-0332991), and it is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6.
Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is "intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints."
Breast cancer is the most commonly diagnosed cancer in women and the leading cause of cancer death among women worldwide. If proved successful, and there's a good chance for that, palbociclib could generate annual sales of $2.4 billion by 2020.
"We appreciate the opportunity that Breakthrough Therapy designation provides to work closely with the FDA on the development of palbociclib. Palbociclib is one example of Pfizer's commitment to identifying and translating innovative science into meaningful new treatment options for cancer patients," said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's oncology business unit.
Pfizer has initiated a randomized, multi-center, double-blind Phase 3 study (known as Study 1008) evaluating palbociclib in combination with letrozole versus letrozole alone as a first-line treatment for post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer. The Breakthrough Therapy designation was based on preliminary Phase 2 data in this patient population. ■