|Amgen R&D chief Sean Harper|
Amgen ($AMGN) is angling for an early FDA nod for the leukemia treatment blinatumomab, racing to market with what the company hopes will be the first of many cancer therapies derived from its proprietary T cell platform.
The drug is an antibody developed through Amgen's bispecific T cell engager (BiTE) system, designed to direct the body's disease-fighting immune cells to attack cancerous growth. Amgen submitted blinatumomab based on promising Phase II data in an aggressive form of the blood and marrow cancer acute lymphoblastic leukemia.
Now the agency accepted Amgen's early application, promising a priority review for the already breakthrough-designated therapy. That lines blinatumomab up for a 6-month trip through the regulatory process, and the FDA expects to hand down a final decision by May 19, Amgen said.
Amgen has moved quickly with blinatumomab since picking it up in a $1.2 billion buyout of Micromet in 2012, and the immunotherapy is also in development as a treatment for chronic lymphocytic leukemia, B-cell lymphoma and other blood and marrow cancers. Beyond blinatumomab, the company is investigating a slew of new BiTE candidates, and Amgen believes its technology has applications in a wide range of cancers.
The drug has become a major pillar of Amgen's late-stage pipeline, standing alongside the much-heralded cardio treatment evolocumab, the cancer vaccine T-Vec and the psoriasis drug brodalumab, all of which could be up for FDA approval next year.
- read the statement