Millennium’s Cancer Drug Velcade Scores Another New Indication

Millennium Pharmaceutical’s received another victory in its efforts to bolster the use of its blockbuster oncology drug Velcade, receiving FDA approval for a new indication for previously untreated patients with mantle cell lymphoma.

Velcade (bortezomib) is the first drug in the U.S. to be approved for previously untreated MCL patients, said Millennium last week. Several drugs are approved for patients with relapsed or refractory MCL but none for patients with previously untreated MCL, the drugmaker added.

The approval was based on a Phase III study that compared untreated patients taking Velcade to those taking a standard treatment regimen of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, said Millennium, the oncology subsidiary of Takeda Pharmaceuticals.

The trial showed a 59 percent relative improvement rate in progression-free survival compared to the standard treatment.

This is the second new Velcade indication in three months to get FDA approval. In August the agency cleared Velcade for the retreatment of adults with multiple myeloma who previously responded to the drug but relapsed for six months or longer after completing the treatment.

Velcade was already approved in the U.S. to treat multiple myeloma.

The push for additional indications could help soften the blow of Takeda’s decision to terminate a development program for an experimental prostate cancer treatment known as TAK-700. Takeda discontinued the program in June after two Phase III trials failed to meet the primary endpoint of overall survival.

Velcade has turned into a profitable commodity for Takeda, generating $337 million in global sales in the second quarter of this year, a 14 percent bump over the same quarter in 2013, according to Takeda’s latest sales figures.

Millennium did not return a request for comment as of press time. — 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.