AstraZeneca ($AZN) scored FDA approval for an expanded indication for its breast cancer drug Faslodex, a win for the company as it looks to cancer drugs to boost its revenues by 2023.
The FDA signed off on Faslodex in combination with Pfizer's ($PFE) Ibrance to treat women with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) who have already received hormone therapy. Faslodex was approved in 2002 to treat postmenopausal women whose cancer worsened after hormone therapy.
The new indication "provides another important treatment option for patients," the company told FiercePharma in an email. Faslodex demonstrates "a clear increase in progression-free survival in patients," Dennis Slamon, chief of the Hematology/Oncology division at UCLA, said in a statement. Regulators based their approval on a Phase III study showing that the Faslodex and Ibrance combo tacked on 4.9 months to patients' lives, meeting its primary endpoint and outshining Faslodex and a placebo.
With the latest approval under its belt, AstraZeneca's "current focus is evaluating the full potential of Faslodex for MBC, the area where we believe patient need is currently the greatest," the company said. "AstraZeneca has a long heritage in breast cancer and is committed to leading the way in developing and optimizing breast cancer therapies for all patient groups."
The new indication gives some additional sales potential to Faslodex, which generated $704 million for AstraZeneca in 2015. The latest approval also gives AstraZeneca some added momentum as it follows through on CEO Pascal Soriot's goal of broadening the company's footprint in oncology. Last year, the company when fighting off Pfizer's unwanted advances said that it would grow its revenue to $45 billion by 2023. And about $12 billion of that haul will come from its most advanced cancer meds, AstraZeneca said at the time.
At least so far, the company seems to be making progress. In November, AstraZeneca snagged FDA approval for its new targeted lung cancer pill Tagrisso. The company has high hopes for the drug, predicting $3 billion in peak sales.
AstraZeneca is also looking to M&A for growth. In December, the company said that it would shell out $7 billion for a majority stake in Acerta Pharma to get its hands on its in-development blood cancer therapy. AstraZeneca management has said that the drug, acalabrutinib, could bring in $5 billion a year at its peak.
- read the statement
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Editor's note: This article was updated with a statement from AstraZeneca.