The US Food and Drug administration has granted breakthrough designation to Pfizer's experimental palbociclib for advanced breast cancers, allowing this potential treatment to reach the market sooner than it would otherwise.
Breakthrough designation was enacted part of the 2012 FDA Safety and Innovation Act (FDASIA) and is designed to hasten development and review for experimental treatments regarded as significant potential advances over existing therapies.
According to Pfizer, palbociclib (PD-0332991) is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6. This means that it inhibits the activity of those enzymes, thereby blocking cell growth and suppressing the copying of cancer cell DNA.
It is being evaluated in a phase 3 trial in combination with letrozole versus letrozole alone as frontline therapy for post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer.
Letrozole (sold as Femara) is an aromatase inhibitor.
Said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology business unit:
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.
The company is also testing the compound against other cancers.
Source: Pfizer
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