Pfizer nabs FDA priority review for potential breast cancer blockbuster
- The FDA has granted Pfizer a priority review for its application to market a combo therapy using its new drug palbocicilib and letrozole for treatment of advanced, HER2-positive breast cancer in postmenopausal women who have not received previous systemic treatment.
- Palbociclib is a cyclin-dependent kinase 4/6 inhibitor that inhibits cell proliferation. The FDA granted the drug breakthrough designation last spring after impressive clinical trial results finding that the treatment more than quadrupled median progression-free survival compared to using letrozole alone.
- A phase II trial found that firstline treatment with the drug combo nearly doubled overall progression-free survival compared to monotherapy, from 10.2 months to 20.2 months.
With priority marketing review in hand, Pfizer could see palbocicilib hit the streets in as soon as six months, setting the company up for a nice 2015 Q3 jolt with a potential blockbuster.
There are several exciting advanced breast cancer drugs inching their way towards the market. For instance, a phase III trial of Roche's Perjeta (pertuzumab) found that the drug was "unprecedented" in extending breast cancer patients' lives. Roche's numbers are still more impressive than Pfizer's topline results; in fact, Perjeta improved progression-free survival by nearly 16 months in patients.