Pfizer wins early FDA approval for a potential cancer blockbuster

Pfizer ($PFE) picked up a speedy FDA nod for palbociclib, a breast cancer treatment with blockbuster potential, barreling toward the market as it works to carve out a bigger share of the oncology space.

The drug, which works by inhibiting the enzymes CDK4 and CDK6, is now cleared for use in postmenopausal women with metastatic breast cancer. The approval is based on Phase II data and comes more than two months ahead of the agency's decision deadline, completing what has been a charmed trip through the regulatory process for Pfizer. The oral treatment, which will sell as Ibrance, is expected to bring in sales between $3 billion and $5 billion a year at its peak, according to Leerink analyst Seamus Fernandez.

FDA oncology chief Dr. Richard Pazdur

The approval puts Pfizer ahead of a coming crowd of CDK inhibitors, including promising contenders from Eli Lilly ($LLY) and Novartis ($NVS), and gives the company a first major success as it begins a new era in cancer treatments. Palbociclib's lightning-fast approval also affirms FDA oncology chief Dr. Richard Pazdur's willingness to hurry along so-called breakthrough treatments that could change the standard of care, a cause for optimism among developers of similar drugs.

Pfizer's drug is specifically indicated for women whose cancers respond to estrogen receptor but don't express human epidermal growth factor receptor 2 (HER2), and it's to be used in combination with the oncology drug Femara (letrozole), the FDA said.

"The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer," Pazdur said in a statement. "The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations."

Pfizer is moving on from last year's pursuit of AstraZeneca ($AZN), a $118 billion gambit driven largely by the allure of that company's immuno-oncology pipeline. In the ensuing months, Pfizer struck a slew of deals to cobble together some promising new assets that could help it catch up with the titans of the field, paying Merck KGaA $850 million up front for the PD-L1 inhibitor MSB0010718C and promising as much as $2 billion more to collaborate on up to 20 new cancer immunotherapies.

The deal took the pressure off of Pfizer and its business development squad in the aftermath of the AstraZeneca debacle, CEO Ian Read said last month, adding that "our research pipeline, middle stage to late stage, is strong, and I would rather take our capital right now and direct it to opportunities to accelerate EPS growth."

And palbociclib's success is an affirmation of Pfizer's ability to compete with the leaders in oncology, Read said in a statement Tuesday.

"I am proud of the clinical program for Ibrance, which was discovered in Pfizer laboratories, and the innovation we are able to bring forward to the breast cancer community today," Read said. "... Today's FDA approval of Ibrance marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need and underscores the contributions our company can make to society."

Pfizer's late-stage pipeline includes bococizumab, a member of a newfangled class of cardio therapies with blockbuster expectations, and ertugliflozin, a Merck ($MRK)-partnered diabetes treatment.

- read the release
- here's Pfizer's statement

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