Pfizer appears to be speeding toward a crucial early FDA approval for palbociclib, a breast cancer treatment with blockbuster potential, pivoting from its failed bid for AstraZeneca and building up an oncology pipeline of its own.
The company is expecting to get final word on the drug by April 13, revealing today that the FDA isn’t going to require it to go through a panel of agency advisers in the meantime. That makes approval look all the more likely to a few analysts, good news for a treatment that has thus far had a charmed trip through the regulatory process. Pfizer submitted a palbociclib application with only Phase II data back in August, quickly winning the FDA’s priority review designation and lining it up for an early approval.
Skipping the advisory panel process, in which independent experts vote whether to recommend approval, could be a sign the agency has already made up its mind, Evercore ISI analyst Mark Schoenebaum wrote in a note to investors. And while the agency could well reject palbociclib anyhow, Schoenebaum believes the news a net positive for Pfizer. Leerink’s Seamus Fernandez, who sees this development as a likely prelude to a regulatory OK, figures the drug could be worth between $3 billion and $5 billion a year at its peak.
Approval for palbociclib, which Pfizer plans to market as Ibrance, would help set the stage for what the company hopes will be a bright future in cancer treatments. Pfizer has apparently moved on from last year’s pursuit of AstraZeneca, a $118 billion gambit driven largely by the allure of the latter 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 immuno-oncology titans Bristol-Myers Squibb, Merck and Roche without the need for a big buyout.
Headlining Pfizer’s swing into immuno-oncology is a deal with Germany’s Merck KGaA, signed in November, under which the U.S. drugmaker will pay $850 million up front and as much as $2 billion more in order to collaborate on up to 20 new cancer immunotherapies. Pfizer also struck a smaller deal with biotech iTeos Therapeutics, handing over a $30 million down payment to get its hands on preclinical drugs that target IDO1 and TDO2, cancer-expressed enzymes that break down tryptophan, which is integral to the immune system’s ability to recognize tumors.
The goal is to contend with industry’s biggest oncology outfits, reversing its trend of checkered results in cancer R&D and building a sustained presence in the field. Palbociclib, which leads similar therapies from Novartis and Eli Lilly, is the first big step forward, and Pfizer could use the victory.
By Damian Garde