Pfizer's Ibrance Gets FDA Approval for Breast Cancer in Men

Pfizer, Inc.’s PFE blockbuster medicine Ibrance gained FDA approval for the treatment of breast cancer in men, thereby expanding the drug’s eligible patient population.

Ibrance, CDK 4/6 inhibitor, can now be prescribed in combination with an aromatase inhibitor or AstraZeneca’s AZN Faslodex (fulvestrant) for the treatment of men with HR+, HER2- metastatic breast cancer. The approval for the expanded indication is based predominately on real-world data, a new approach to expanding the use of already approved innovative medicines.

Ibrance has been generating strong sales and is a key driver of the company’s top line. The drug generated sales of $4.1 billion in 2018. With the expanded label, the drug should bring in more sales

Shares of Pfizer have declined 2% so far this year against the industry’s 4.4% increase.


Ibrance is a key drug in Pfizer’s oncology portfolio. The company is 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.

However, competition in the breast cancer market has risen with launch of Eli Lilly’s LLY Verzenio and Novartis’ NVS Kisqali in the past couple of years. Nonetheless, in key markets like the United States, Europe and Japan, Ibrance has maintained greater than 90% share of total CDK inhibitors class volume despite rising competition,.

Pfizer currently carries a Zacks Rank #4 (Sell).

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