Venetoclax Combo Approved for Older Patients With Acute Myeloid Leukemia

The FDA has now granted full approval to venetoclax (Venclexta®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for patients with previously untreated acute myeloid leukemia (AML) who are at least 75 years of age or who have comorbidities that prevent them from receiving intensive induction chemotherapy. Previously, this venetoclax combination therapy was granted accelerated approval in 2018 for use in this same patient population. The ...
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Nivolumab/Ipilimumab Approved: Malignant Pleural Mesothelioma

The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...
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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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