01/24/2012 1 Comment Contact Our News Editors

By Lori Valigra

Cambridge cancer pharmaceutical firm Millennium: The Takeda Oncology Company said Monday that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for its Velcade (bortezomib) drug to include subcutaneous administration.

The FDA nod is for all approved indications of Velcade — multiple myeloma and mantle cell lymphoma after at least one prior therapy, the company said.

The approval was based on results from a randomized Phase 3 trial in 222 patients with relapsed multiple myeloma who had not previously taken Velcade. The primary goal of the trial was to show that single-agent subcutaneous Velcade retained at least 60 percent of the overall response rate after four cycles compared to single-agent intravenous drug administration. The secondary endpoints of the study included safety and tolerability, time to progression, progression-free survival and one-year overall survival.

“Subcutaneous Velcade is yet another advance in the management of patients with multiple myeloma or relapsed mantle cell lymphoma,” Dr. Karen Ferrante, chief medical officer at Millennium, said in a statement. “The consistency in efficacy findings, and observed differences in peripheral neuropathy, allow physicians to tailor Velcade treatment for their patients.”

Dr. Noopur Raje, director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, said the new subcutaneous route of administration for Velcade is especially useful for patients with poor vein access and those with pre-existing peripheral neuropathy or a high risk of developing peripheral neuropathy. “It’s important to have a range of treatment options to provide the best possible care to each individual patient,” Raje said.

Velcade was co-developed by Millennium and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of Velcade in the United States, while Janssen is responsible for commercialization in Europe and the rest of the world. The drug is approved in more than 90 countries and has been used to treat more than 300,000 patients, the company said.

The company in December told Mass High Tech that it is adding manufacturing suppliers in the wake of a series of precautionary recalls for its Velcade treatment in the United States and Europe. The company issued recalls for Velcade in the United States last December and in November 2010. And in November 2011, the European Medicines Agency recommended a recall for partner Johnson & Johnson’s Velcade in Europe. The reason for the recalls is potential contamination risks found at contract manufacturer Ben Venue Laboratories in Bedford, Ohio.

Millennium CEO Deborah Dunsire told Mass High Tech that the European Medicines Agency and the U.S. FDA had sufficient question marks about the full control of production at all times at the plant, so Millennium decided to voluntarily pull the drug.

“We have two other suppliers, so there will be no interruption in the supply,” she said, adding that the company has been increasing the supply of Velcade from the other suppliers for a period of time and will continue to ramp up the quantities from the most recent supplier, which was approved by the FDA last March.