Pfizer’s breast cancer drug receives BTD from US FDA
Following the news last week that Janssen’s leukaemia drug had received its third Breakthough Therapy designation (BTD), Pfizer has also announced that it has received this special status from the US FDA.
The US FDA granted Pfizer’s investigation compound palbociclib (PD-0332991), which is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, with a Breakthrough Therapy designation for the potential treatment of patients with breast cancer.
Breakthrough Therapy designation is intended to speed up 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.”
“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.”
Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology business unit.
Pfizer will continue to work with the FDA to better understand the implications of Breakthrough Therapy designation on the palbociclib development program and to generate evidence needed to support a potential regulatory submission.
The global pharma company has begun phase 3 clinical trials 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.
Breast cancer is the most commonly diagnosed cancer in women and the leading cause of cancer death among women worldwide.
Pfizer breast cancer drug gets breakthrough label (Wall Street Journal)
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