FDA Approves Velcade in Mantle Cell Lymphoma

FDA approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma.

The approval is based on the results of an international, randomized, head-to-head phase III study that showed that previously untreated patients receiving a bortezomib-containing combination (bortezomib, rituximab [Rituxan], cyclophosphamide, doxorubicin, and prednisone) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (HR=0.63; p < .001)

The open-label prospective study evaluated 487 patients with previously untreated mantle cell lymphoma who were ineligible or not considered for a bone marrow transplant.

Patients in the bortezomib arm had a median PFS of 25 months, compared to 14 months in patients who received the standard R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) at a median follow-up of 40 months. The complete response rate for patients receiving the bortezomib combination compared to R-CHOP was 44 vs. 34 percent.

Bortezomib was previously approved for the treatment of relapsed or refractory mantle cell lymphoma in 2006.

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FDA Approves Velcade in Mantle Cell Lymphoma

YOU MAY BE INTERESTED IN

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patientsCaveat: The guidance is optional. Will states opt in?

Scientific progress can’t help people if they can’t access careThis is a policy problem. And it is one we can change.

The end of “more money, more people, more trials”Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words“When you fight poverty, you‘re fighting a humanitarian battle for all people.”

Never miss an issue!

Login

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI
“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patients
Caveat: The guidance is optional. Will states opt in?

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93
Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words
“When you fight poverty, you‘re fighting a humanitarian battle for all people.”