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Pfizer Ibrance sNDA Accepted by FDA under Priority Review
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Pfizer Inc.'s (PFE - Free Report) 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 - Free Report) Femara (letrozole), as initial endocrine-based therapy in postmenopausal women. It is also indicated in with AstraZeneca plc’s (AZN - Free Report) 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.
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corporation , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 14.6% year to date.
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Pfizer Ibrance sNDA Accepted by FDA under Priority Review
Pfizer Inc.'s (PFE - Free Report) 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 - Free Report) Femara (letrozole), as initial endocrine-based therapy in postmenopausal women. It is also indicated in with AstraZeneca plc’s (AZN - Free Report) 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.
PFIZER INC Price
PFIZER INC Price | PFIZER INC Quote
Zacks Rank & a Key Pick
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corporation , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 14.6% year to date.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>