publication date: Oct. 30, 2014

FDA Approves Velcade Injection 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.

 

FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.

Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase after the start of … Continue reading CCL Oct – Drugs and Targets

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