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.
FDA granted priority review status to lenvatinib mesylate as a treatment for progressive radioactive iodine-refractory differentiated thyroid cancer.
Developed by Eisai Inc., lenvatinib is an oral multiple receptor tyrosine kinase inhibitor that blocks the kinase activities of vascular endothelial growth factor receptors, in addition to other proangiogenic and oncogenic pathway-related tyrosine kinases thought to be involved in tumor proliferation. These include fibroblast growth factor receptors, the platelet-derived growth factor receptor PDGFR, KIT and RET, which are thought to be involved in tumor proliferation.
Lenvatinib was granted orphan drug designation in various types of thyroid cancer in the U.S., Japan, and Europe. It is currently under investigation in thyroid, hepatocellular, endometrial, non-small cell lung cancer, and other solid tumor types.
FDA granted priority review to the investigational bispecific T-cell engager antibody construct blinatumomab for the treatment of adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.
Amgen, the drug’s sponsor, also submitted a marketing authorization application to the European Medicines Agency. The submissions include data from a phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.
Blinatumomab, the first of Amgen’s investigational BiTE antibody constructs, has received orphan drug designation from the EMA and FDA, and breakthrough therapy and priority review designation from the FDA for the treatment of ALL.
Blinatumomab is designed to direct T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Blinatumomab is also being investigated in pediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive B-precursor ALL, minimal residual disease positive B-precursor ALL, relapsed/refractory non-Hodgkin’s lymphoma, including relapsed/refractory diffuse large B-cell lymphoma.