Multiple Myeloma

FDA Approves Additional Multiple Myeloma Indication for Empliciti

By November 07, 2018

Approval was based on results from ELOQUENT-3, a Phase 2, open-label trial (N=117) involving patients with relapsed or refractory multiple myeloma.

Kyprolis Labeling Updated With Overall Survival Data From Multiple Myeloma Trial

By June 11, 2018

ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) was a Phase 3 trial that evaluated the triplet regimen Kyprolis, lenalidomide, and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) alone, in patients with relapsed or refractory multiple myeloma who received 1-3 prior regimens.

Darzalex + VMP Approved for New Diagnosed Multiple Myeloma

By May 08, 2018

VMP consists of Velcade, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone, a steroid.

Shorter overall survival among patients with monoclonal gammopathy of undetermined significance

January 23, 2018

Patients diagnosed with monoclonal gammopathy of undetermined significance (MGUS) and followed for multiple decades showed shorter overall survival rates compared to matched controls.

Overall Survival Data Added to Labeling for Multiple Myeloma Drug Kyprolis

By January 18, 2018

Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival by 7.6 months.

Xgeva Approved to Prevent Skeletal-Related Events in Multiple Myeloma Patients

By January 05, 2018

The approval is based on data from the pivotal Phase 3 '482 study, the largest international multiple myeloma clinical trial ever conducted.

FDA Issues Statement on Keytruda Studies for Multiple Myeloma

By August 31, 2017

The FDA will continue to monitor outcomes from other multiple myeloma clinical trials of Keytruda (KEYNOTE-023 Cohort 1), other PD-1/PD-L1 cancer drugs, and other combinations.

Revlimid Approved as Maintenance Therapy in Multiple Myeloma

By February 23, 2017

Adverse events seen in these trials were similar to those previously described in the lenalidomide product labeling.