Dive Brief:
- 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.
Dive Insight:
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.