Pfizer cancer drug takes big step toward fateful FDA decision

After wrapping up an orphan drug designation and fast track status late last year, Pfizer can now add a priority review stamp to its list of accomplishments for crizotinib, its late-stage lung cancer drug which represents one of the Big Pharma's brightest hopes for a major near-term approval. And Pfizer says that it has simultaneously filed a marketing application for the cancer drug-which targets a slice of the market for non-small cell lung cancer--with both U.S. and Japanese regulatory authorities.

"Our ability to file applications for regulatory review in the U.S. and Japan simultaneously only three years after beginning worldwide clinical trials in patients with ALK-positive lung cancer is a testament to the hard work of the crizotinib team and the productive discussions that we have had with the respective regulatory agencies. Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.

For Pfizer, which has had to endure years of harsh criticism about drug programs gone awry and only two new blockbuster drug approvals over a decade--despite $70 billion in R&D costs--crizotinib is crucial. It sits beside tofacitinib for rheumatoid arthritis, the blood thinner apixaban and Prevnar 13 for adults as one of Pfizer's top tier blockbuster contenders.

Facing a dangerous patent cliff, Pfizer's new CEO Ian Read has been rethinking how the company--which long boasted the biggest R&D budget in the industry--is structured. Billions of dollars are being slashed from the research budget as Read considers revamping the business and selling off various units and reducing the business to its core drug operation.

- here's the Pfizer release
- read the story from the Wall Street Journal

Special Report: Crizotinib - 10 promising late-stage cancer drugs