Pfizer Ibrance sNDA Accepted by FDA under Priority Review
Pfizer Inc.'s PFE supplemental new drug application (sNDA) to convert accelerated approval for its breast cancer drug, Ibrance, to regular approval was accepted by the FDA under priority review.
Note that Ibrance is approved in the U.S. for the treatment of HR+/HER2- advanced or metastatic breast cancer, in combination with Novartis AG’s NVS Femara (letrozole), as initial endocrine-based therapy in postmenopausal women. It is also indicated in with AstraZeneca plc’s AZN Faslodex in women with disease progression following endocrine therapy. The Ibrance, in combination with Femara, was cleared in the U.S. under accelerated approval and Pfizer is now looking to get regular approval for the drug based on data from the phase III PALOMA-2 trial.
Pfizer’s shares gained 3.1% in the past one month, comparing favorably with an increase of 2.9% for the Zacks classified Large Cap Pharma industry.
According to the press release, priority review for the drug means that a response should be out in Apr 2017.
PALOMA-2 evaluated a total of 666 women in 186 global sites in 17 countries. Results from the study revealed that the combination of Ibrance and Femara led to an improvement in progression-free survival (PFS) when compared to Femara plus placebo in post-menopausal women with advanced or metastatic breast cancer.
We remind investors that Ibrance received accelerated approval from the FDA in Feb 2015 based on data from phase II PALOMA-1 study.
Meanwhile, Ibrance, in combination with endocrine therapy, is under review in the EU for the treatment of HR+, HER2- advanced or metastatic breast cancer. The company plans to submit the PALOMA-2 study data to support the ongoing review.
Ibrance is the first and only FDA approved oral inhibitor of CDKs 4 and 6. Moreover, the drug has received the regulatory nod in more than 50 countries.
Ibrance has been off to a strong start, registering sales of $1.5 billion in nine months ended Oct 2016. Label as well as geographical expansion would boost the drug’s commercial potential significantly. We expect investor focus to remain on the commercialization and sales ramp-up of Ibrance, going forward.
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Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corporation CBM, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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