Updated from 9:48 a.m. EDT
said Wednesday that its experimental cancer drug, MLN341, has been granted "fast track" status by U.S. drug regulators.
This allows the drug, which is being developed as new treatment for multiple myeloma, the second most common blood cancer, to be reviewed by the Food and Drug Administration on an accelerated basis. Specifically, the FDA will review portions of Millennium's approval application as they are submitted, rather than after the entire document is filed.
Millennium intends to begin a pivotal, Phase III test of MLN341 by the end of June. The 600-patient clinical trial, if successful, will be used as the basis for the FDA approval application. An FDA decision on the drug's approvability could come by late 2004.
Last month, Millennium took the wraps off positive Phase II test
results for MLN341 at the annual meeting of the American Society of Clinical Oncology.
The Phase III clinical trial will enroll patients who suffer from an intermediate stage of multiple myeloma, meaning that they have received chemotherapy, thalidomide, or bone marrow transplants but the cancer is still progressing. Half the patients in the study will receive a combination of MLN341 and the chemo drug dexamethasone, while the other half will receive just dexamethasone.
Patients who receive dexamathesone, alone, typically can go six to nine months before the cancer starts growing again. Millennium hopes to show that the addition of MLN341 will slow the time the disease starts growing by a minimum of 30%, "but our expectations are that
MLN341 will do much better than that," says John Maraganore, Millennium's senior vice president of product development.
Maraganore adds that the protocol for the Phase III trial allows patients in the dexamethasone arm to also receive MLN341 once their cancer starts growing again.
In addition to MLN341, the FDA has also granted fast-track status to the company's experimental cancer drug, MLN518, which is currently in earlier-stage development for acute myeloid leukemia.
Shares of Millennium closed Tuesday at $12.98 per share.