Millennium Nabs Additional Indication for Cancer Drug Velcade

The agency approved Velcade (bortezomib) for the retreatment of adults with multiple myeloma who previously responded to Velcade therapy and relapsed six months or longer after completion of that treatment. The drug is already approved to treat multiple myeloma in the U.S., Europe and more than 90 other countries, said Millennium, the oncology-focused subsidiary of Takeda Pharmaceuticals.

The FDA approved the sNDA based on a Phase II trial of 130 patients who had a partial response or better following treatment with Velcade, but relapsed six months later. When retreated with Velcade, the overall response rate among patients was 38.5 percent, Millennium said.

This isn’t the only indication Millennium is pursuing for Velcade. The company has filed a regulatory submission to treat front-line mantle cell lymphoma, and expects approval sometime next year. Velcade is already approved to treat mantle cell lymphoma in patients who have received at least one prior treatment.

Velcade has proved a moneymaker for Takeda, generating nearly $35 million in sales in the second quarter of this year. That represents a 14.6 percent bump over last year’s sales for the same period, according to Takeda’s latest financial report. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.