Velcade Approved for the Retreatment of Multiple Myeloma

The US Food and Drug Administration has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma who previously responded to the drug only to relapse at least six months after completing therapy.

This is according to the dru's manufacturer, Millenmnium Pharmaceuticals.

Bortezomib is used as a single-agent treatment or in combination with dexamethasone.

"for the past 11 years Velcade has played an important role as the only therapy proven to extend overall survival for patients with newly diagnosed and relapsed multiple myeloma," said Michael Vasconcelles, MD, Global Head, Oncology Therapeutic Area Unit, Takeda. "With these newly approved dosing guidelines, physicians will be able to provide their patients, who have previously received Velcade, with an effective treatment extending Velcade use across the continuum of care of multiple myeloma."

Approval for this indication comes from the RETRIEVE trial, a single-arm, open-label trial that enrolled 130 patients ages 18 and older who had previously responded to Velcade-based therapy and relapsed at least six months after prior treatment with Velcade.

Source: Takeda