Pfizer’s Breast Cancer Drug Approved Two Months Early by FDA

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Pfizer Inc.’s drug Ibrance was approved for advanced breast cancer by U.S. regulators more than two months ahead of schedule, letting the drugmaker proceed with one of its most promising new blockbusters.

The drug was authorized under the Food and Drug Administration’s accelerated approval program and will be used as a therapy against one of the deadliest forms of breast cancer. It’s the first therapy to be approved as an initial option for treatment of this form of breast cancer in more than 10 years, the company said.

“Today’s FDA approval has the potential to significantly impact the way oncologists treat thousands of women with advanced breast cancer across the U.S.,” Chief Executive Officer Ian Read said in a statement.

Pfizer estimated Ibrance could be an option for treatment in as many as 22,000 women a year who have advanced ER-positive, HER2-negative breast cancer. The company will charge $9,850 for a month’s supply of the drug before any discounts.

The drug gives Pfizer a boost in its search for the next big hit after a series of patent expirations. Sales of Ibrance are expected to exceed $3 billion by 2019, according to a Bloomberg survey of eight analysts, which would make it one of the company’s top-selling drugs that year.

Shares of Pfizer rose less than 1 percent to $32.11 in early trading Wednesday.

Pfizer’s sales have been falling from their $67.1 billion peak in 2010, the year after the company acquired Wyeth in a transaction valued at more than $60 billion. Sales this year are estimated by analysts to be $46.2 billion.

Pfizer’s Future

The company has been looking for an acquisition target after failing to buy AstraZeneca Plc last year for about $120 billion in what would have been the industry’s biggest-ever acquisition. The drugmaker has looked at other options including Teva Pharmaceutical Industries Ltd. and Actavis Plc, according to people familiar with the matter.

Oncology has been a major focus for the Pfizer, the U.S.’s biggest drugmaker. The company forged a deal to jointly develop and sell Merck KGaA’s cancer drug in November for $850 million, adding a late-stage prospect in a class of new medicines that trigger the immune system to attack tumors, one of the industry’s hottest areas.

Drugmakers like Merck & Co. and Bristol-Myers Squibb Co. have been leading the pack in developing drugs that use the immune system to attack tumors.

The market for immune-oncology drugs may be worth $40 billion a year or more a decade from now, according to Leerink Partners. Last year’s abandoned bid for AstraZeneca was predicated in part on a desire for the London-based company’s cancer pipeline.

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