Pfizer Gets Regular Approval for Breast Cancer Drug Ibrance

Pfizer, Inc. PFE announced that its supplemental new drug application (sNDA) to convert accelerated approval for Ibrance to regular approval has been approved by the FDA.

Pfizer’s shares are up 5.3% so far this year, comparing unfavorably with the Zacks classified Large-Cap Pharma industry’s return of 6.1%.

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 to be used with AstraZeneca plc’s AZN Faslodex in women with disease progression following endocrine therapy. We remind investors that Ibrance, in combination with Femara, was cleared in the U.S. under accelerated approval in Feb 2015.

Pfizer has now received regular approval for the drug based on data from the phase III PALOMA-2 trial.

Also, with the latest approval, Ibrance’s indication has been expanded to be used in combination of any aromatase inhibitor and not just letrozole.

The PALOMA-2 study evaluated the combination of Ibrance and Femara (letrozole) for the treatment of first-line ER+, HER2- metastatic breast cancer.

In the study, it was seen that a combination of Ibrance and Femara led to an improvement in progression-free survival (PFS), or the time before tumor growth, by more than 10 months compared with Femara plus placebo.

We remind investors that in November last year, Ibrance was approved in the EU in combination with an aromatase inhibitor for the treatment of HR+/HER2- locally advanced or metastatic breast cancer.

Ibrance has been generating strong sales and is a key driver of the company’s top line. The drug generated sales of $2.1 billion in 2016. With the expanded label, the drug should bring in more sales.

Pfizer is also exploring the possibility of expanding Ibrance into recurrent and subsequent early breast cancer as well as several non-breast cancer indications like pancreatic and head and neck cancers.

Pfizer carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Roche Holding AG RHHBY with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Roche have risen 12.2% this year so far while earnings estimates for 2017 have gone up by almost 12% in the past 30 days.

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