FDA Approves Belantamab Mafodotin-blmf for R/R Multiple Myeloma

Belantamab mafodotin-blmf (BLENREP®, GlaxoSmithKline) was recently FDA approved for adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have previously failed four therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Approval was based on DREAMM-2 (NCT03525678), an open-label, multicenter trial that enrolled 293 patients with R/R MM with disease progression after three or more lines of prior therapy and who were refr...
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Oral Decitabine/Cedazuridine for MDS: Olatoyosi Odenike, MD

In this interview, Olatoyosi Odenike, MD, speaks with i3 Health about the approval of oral decitabine/cedazuridine (Inqovi®, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS). Dr. Odenike, Director of the Leukemia Program at the University of Chicago and an investigator of one of the clinical trials on which the approval was based, discusses the challenges of treating patients with MDS and the significance of the approval of oral decitabine/cedazuridine. What a...
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Transplant-Ineligible Diffuse Large B-Cell Lymphoma: Tafasitamab/Lenalidomide Approved

The FDA has granted accelerated approval to tafasitamab-cxix (Monjuvi®, MorphoSys US Inc.) in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are ineligible for autologous stem cell transplantation. The approval of tafasitamab, a CD19-directed cytolytic antibody, is based on efficacy data from the single-arm, international phase 2 L-MIND trial (NCT02399085), wh...
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Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...
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First CAR T-Cell Therapy Approved for Mantle Cell Lymphoma

The FDA has now granted accelerated approval to brexucabtagene autoleucel (TecartusTM, Kite Pharma, formerly known as KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is the first CAR T-cell therapy approved for this rare type of B-cell non-Hodgkin lymphoma. Efficacy was evaluated in the multicenter, open-label phase 2 ZUMA-2 trial (NCT02601313), which enrolled 7...
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