Amgen beats a path to the FDA, looking for an early approval of leukemia drug

Amgen ($AMGN) is getting aggressive with one of its midstage leukemia drugs. In its earnings call with analysts the big biotech's R&D chief called out blinatumomab, saying that recent Phase II data might warrant an early approval.

Amgen R&D Chief Sean Harper

"We also recently reviewed the blinatumomab confirmatory Phase II results in relapsed/refractory adult acute lymphoblastic leukemia," said Sean Harper during his time on the stage. "These data, which will also be presented at ASCO, continue to support a positive benefit-risk profile in these patients who have exhausted other therapeutic options. We're therefore initiating discussions with regulators on the potential for filing based on these data."

The leukemia program for blinatumomab has been flying low on the radar screens at Amgen ever since then-R&D director Roger Perlmutter picked it up in a buyout of Micromet two years ago for $1.2 billion.

The drug is a bispecific T cell engager (BiTE) which, simply put, uses an antibody to redirect killer T cells to destroy tumor cells. New immunotherapies that spur an immune system attack on cancer have become a hot field in cancer, which has been attracting some heavy investments among the Big Pharma crowd. And Perlmutter--now head of R&D at a resurgent Merck ($MRK)--had become clearly enamored with the drug when he decided to buy out the biotech.

For Amgen, the drug emerges as a potential near-term prospect for marketing. Their discussions about seeking an early approval also highlight the regulatory shortcuts that development teams have been looking for--or are pointed to. Pfizer's ($PFE) closely watched cancer drug palbociclib has successfully wrapped a midstage study, sparking some considerable excitement among analysts who would like to see the giant pharma go for it. Pfizer, though, still hasn't clarified what its development strategy will be.