Pfizer's promising results for palbociclib stir talk of early approval push

Mace Rothenberg, chief medical officer, Pfizer Oncology--Courtesy of Vanderbilt University

A few days ago, as Pfizer ($PFE) executives reviewed the pharma giant's numbers for 2013 and plans for 2014, analysts detected a growing willingness to see if they could hunt up an accelerated approval for palbociclib if the Phase II study for breast cancer rang up promising results. And this morning the handicappers in the industry were upping the odds on Pfizer doing just that as investigators partially pulled back the covers on a significant but unspecified improvement in progression-free survival.

"Recall that PFE has previously said that if the data warranted it, PFE would discuss with the FDA the potential to file based on these Phase II data via accelerated approval," noted ISI's Mark Schoenebaum within minutes of Pfizer's release.

Pfizer didn't come right out and say that it would shoot for an early approval of the drug ahead of Phase III data, but it's clearly going on the table for discussion at the FDA. Pfizer's stock surged 3% on the news, as investors pondered the possibilities of a drug that some analysts believe has the potential to earn $5 billion to $6 billion a year.

"We are delighted with the final data, which suggest the potential for palbociclib to transform the standard of care for post-menopausal women with ER+ and HER2- advanced breast cancer," said Dr. Mace Rothenberg, chief medical officer for Pfizer Oncology, in a statement. "This is encouraging information for these women, who represent approximately 60% of the advanced breast cancer population. We will discuss these results with the FDA and other regulatory authorities to determine next steps, with the goal of bringing a much-needed new medicine to patients."

Palbociclib grew in importance for Pfizer after the recent failure of dacomitinib in two late-stage lung cancer studies. The pharma giant identified cancer as one of its most important R&D fields in a wrenching R&D restructuring, and palbociclib represents a rare shot at a potential megablockbuster oncology franchise.

If Pfizer does take a shot at an accelerated approval, the move would also underscore the FDA's growing willingness to consider shorter regulatory pathways for new drugs. Palbociclib was one of the first experimental therapies to win the FDA's "breakthrough" drug designation, giving it VIP status at the agency. It may be a long shot, but any move that could potentially carve time out of the development cycle will be closely watched by the industry.

- here's the press release

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