Amgen's Blincyto puts leukemia patients in remission, building its case for a new FDA nod

Amgen's ($AMGN) working to expand the label of cancer-fighter Blincyto, and on that front, it's got some solid new data to help it make its case.

In a Phase II study, a "clinically meaningful" number of relapsed or refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (ALL) patients taking the drug experienced complete remission or complete remission with partial hematological recovery, the company said Thursday.

It's a promising showing for Amgen, which is looking to rack up another nod for Blincyto. The FDA approved the immunotherapy late last year to treat patients with the Philadelphia chromosome-negative form of the disease, handing down a green light more than 5 months ahead of schedule.

And if Blincyto does eventually nab a second ALL indication, the California drugmaker is hoping it won't be its last go-ahead. Since picking up the med in a $1.2 billion buyout of Micromet in 2012, Amgen has been working on developing it as a treatment for chronic lymphocytic leukemia (CLL), B-cell lymphoma and other blood and marrow cancers.

Blincyto isn't Amgen's only cancer treatment in pursuit of new uses, either. The company is hoping Kyprolis--acquired through its 2013 Onyx Pharmaceuticals buyout--can win an FDA bump-up from the third line of therapy to the second line in relapsed multiple myeloma patients. In March, the agency fast-tracked Amgen's application for the new use, and if decides in Amgen's favor, it'll open up a larger patient population that stays on Kyprolis for a longer period of time.

- read Amgen's release

Special Reports: The new drug approvals of 2014 - Blincyto | The top 15 pharma companies by 2014 revenue - Amgen

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