TRENTON, N.J. – Pfizer Inc. said Friday that the Food and Drug Administration will let the drugmaker apply for approval of its heavily touted experimental breast cancer medicine based on midstage patient testing results.
That means New York-based Pfizer won’t have to do bigger, and very expensive, late-stage patient studies to apply for approval of palbociclib, as company executives and investors had hoped.
Having to run those additional studies could have delayed Pfizer’s application by up to a couple of years, keeping patients and doctors waiting and ultimately reducing how much money the drug could bring Pfizer before its 20-year patent expires.
Pfizer, the world’s second-biggest drugmaker by revenue, said that after discussions with the FDA, the final results of a study called PALOMA-1 will be sufficient for review.
Pfizer said that by the third quarter of this year, it will apply for approval to use palbociclib with a drug called Femara, or letrozole, as an initial treatment for postmenopausal women with a certain type of advanced breast cancer.
The FDA last year named palbociclib a breakthrough therapy, a designation given to medicines for diseases with no or inadequate treatments. It’s meant to speed up the testing and approval process. The designation was based on interim results from the PALOMA-1 study.
Those showed that by combining palbociclib with letrozole, patients on average survived 20.2 months before their tumors worsened. That was about twice as long as the benefit for women in a comparison group who only received letrozole.
Pfizer has already begun two late-stage studies of palbociclib, and breast cancer researchers in Spain and Germany are doing their own studies testing it in combination with other treatments.
BernsteinResearch analyst Dr. Timothy Anderson wrote to investors that Pfizer’s discussions with the FDA “should not be viewed as an implicit approval of sorts,” but that he does expect approval.
“We currently forecast a launch of palbociclib in 2015 with sales reaching $1.9 (billion) in 2020,” Anderson wrote, noting that rivals Novartis AG and Eli Lilly and Co. aren’t far behind Pfizer in their development of similar drugs.
Pfizer shares initially jumped 1.7 per cent on the news and were up 15 cents at $29.21 in midafternoon trading.
Follow Linda A. Johnson at www.twitter.com/LindaJ_onPharma