Single-Agent Nivolumab Withdrawn for Hepatocellular Carcinoma Treatment

In consultation with the FDA, Bristol Myers Squibb has voluntarily withdrawn nivolumab (Opdivo®) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. Nivolumab had previously been granted accelerated approval from the FDA in 2017, which was based on the phase 1/2 CheckMate 040 clinical trial (NCT01658878). The withdrawal of this treatment is due to the lack of statistical significance in the final overall survival results of...
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New Pembrolizumab Indications Approved for Triple-Negative Breast Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) for patients with high-risk early-stage triple-negative breast cancer (TNBC) as neoadjuvant treatment in combination with chemotherapy and as single-agent adjuvant treatment following surgery. In addition, the FDA has confirmed the November 2020 accelerated approval of pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC with a programmed death ligand 1 (PD-L1) combined ...
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FDA Grants Regular Approval to Pembrolizumab/Lenvatinib Combination for Endometrial Carcinoma

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck), in combination with lenvatinib, (Lenvima®, Eisai), for patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Prior to this regular approval, the FDA granted accelerated approval to the pembrolizumab/lenvatinib co...
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FDA Approves Belumosudil for Chronic Graft-Versus-Host Disease

The FDA has granted approval to belumosudil (Rezurock™, Kadmon Pharmaceuticals, LLC), for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. "Belumosudil (KD025) is a novel oral selective Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor specifically designed for the treatment of chronic GVHD," wrote Corey S. Cutler, MD, MPH, FRCPC, Medical Director of the Adult Stem Cell Transplantation...
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FDA Approves Daratumumab and Hyaluronidase-Fihj With Chemo and Steroid for Multiple Myeloma

The FDA has granted approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. "In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response," wrote Meletios A. Dimopoulos, MD, Professor and Chairman of the Department of C...
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