Hans C. Lee, MD: FDA Approval of Belantamab Mafodotin-blmf for R/R Multiple Myeloma

For patients with relapsed or refractory (R/R) multiple myeloma (MM), a new treatment has just been recently FDA approved: belantamab mafodotin-blmf (BLENREP®, GlaxoSmithKline). In an interview with i3 Health, Hans C. Lee, MD, of The University of Texas MD Anderson Cancer Center, speaks about the significance of this approval and what the future may look like on treating these patients. What are the most challenging aspects of treating patients with R/R MM? Hans C. Lee, MD: While there have been...
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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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John Leonard, MD: FDA Approval of Selinexor for DLBCL

Selinexor (Xpovio®, Karyopharm Therapeutics) was recently FDA approved to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This approval extends to patients with DLBCL that resulted from follicular lymphoma and those who had previously received at least two prior lines of systemic therapy. John Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine, discussed with i3 Health the importance of this approval and the fu...
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Avelumab for Urothelial Carcinoma: An Interview With Thomas Powles, MBBS, MRCP, MD

The FDA recently approved avelumab (Bavencio®, EMD Serono, Inc.) for patients with advanced urothelial carcinoma (UC). Thomas Powles, MBBS, MRCP, MD, discusses with i3 Health the implication of this approval and future steps for research and offers community oncologists advice on treating this patient population. What are the most challenging aspects of treating patients with locally advanced or metastatic UC? Thomas Powles, MBBS, MRCP, MD: The overall survival outcomes are poor for the disease....
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The Changing Standards for FDA Oncology Approvals: Talal Hilal, MD

The FDA approval process is in place to ensure that drugs are safe and effective before they are made available to the public. But do the clinical trials that lead to approval truly ascertain whether a drug is efficacious? Fully two-thirds of anticancer drug clinical trials leading to FDA approvals between 2014 and 2019 had at least one important limitation in trial design: lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and/or use of a...
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