Pfizer Inc. PFE announced that its supplemental New Drug Application for breast cancer drug, Ibrance, will be reviewed on a priority basis by the FDA. This means that a response should be out by Apr 2016.
Pfizer is looking to include data from the PALOMA-3 study in Ibrance’s label. The phase III PALOMA-3 study evaluated Ibrance plus AstraZeneca’s AZN Faslodex (fulvestrant) versus Faslodex plus placebo in women with HR+/HER2- metastatic breast cancer whose disease progressed after prior endocrine therapy, including those with and without prior treatment for their metastatic disease.
We remind investors that Ibrance was approved by the FDA in Feb 2015. The drug was approved in combination with Novartis AG’s NVS Femara (letrozole) for the first-line treatment of postmenopausal women with estrogen receptor-positive, HER2- advanced breast cancer as an initial endocrine-based therapy for their metastatic disease. Sales of Ibrance have gained strong momentum so far in 2015 since its launch.
Meanwhile, Pfizer and Bristol-Myers Squibb Company BMY announced results from a post hoc early-time course subanalysis of the phase III AMPLIFY (apixaban for the initial management of pulmonary embolism and deep vein thrombosis as first-line therapy) study. In the study, it was found that Eliquis was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin dose-adjusted to an international normalized ratio of 2 to 3) in recurrent venous thromboembolism (VTE) and VTE-related death, with significantly less number of incidents of major bleeding during the first 7, 21 and 90 days after starting treatment.
Pfizer currently carries a Zacks Rank #2 (Buy). Bristol-Myers is another favorably ranked stock in the health care sector carrying the same Zacks Rank as Pfizer.
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