Velcade Now Approved in Combination for Untreated Mantle Cell Lymphoma

According to the manufacturer, Velcade (bortezomib) has been approved by the US FDA in combination with other drugs for the treatment of patients with previously untreated mantle cell lymphoma (MCL).

Velcade has been an approved treatment for relapsed or refractory MCL since 2006. It is also approved for patients with multiple myeloma.

This newest indication means that it can be administered as part of what is now being called the VcR-CAP regimen, but over the summer was called the VR-CAP regimen.

The FDA has based approval on results of the LYM-3002 trial, which recruited patients with previously untreated MCL and randomized them to receive either standard therapy-- which is the familiar combination chemotherapy regimen R-CHOP -- or VR-CAP, which is simply the same combination as R-CHOP except you remove the vincristine and replace it with Velcade.

Results of the trial indicated that there was a higher rate of complete response in VR-CAP compared to R-CHOP (44 percent vs 34 percent) and a longer median progression-free survival (25 months vs 14 months).

However, the VR-CAP regimen in this trial also resulted in more adverse events and was associated with higher toxicity than R-CHOP.

Source: Healio