On May 19, 2023, Epcoritamab-bysp (Epkinly, Genmab US, Inc) was granted accelerated approval by the US FDA for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 23, 2024, the U.S. Food and Drug Administration granted accelerated approval for tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for relapsed or refractory pediatric low-grade
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 29, 2024, the U.S. Food and Drug Administration granted regular approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for
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FDA Approves Lutetium Lu 177 Dotatate for SSTR-Positive Gastroenteropancreatic Neuroendocrine Tumors
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 23, 2024, the U.S. Food and Drug Administration granted approval for lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company)
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 18, 2024, the U.S. Food and Drug Administration granted approval to a potent oral ALK (anaplastic lymphoma kinase) tyrosine kinase inhibitor – Alectinib (Alecensa,
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 22, 2024, the U.S. Food and Drug Administration granted approval for nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC), to be used in conjunction with
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By Dr. Anish Shah Bronx Lebanon Hospital On August 9, 2023, the U.S. Food and Drug Administration approved talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with multiple myeloma with relapsed or
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On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR)
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On June 15, 2023, the U.S. Food and Drug Administration approved Glofitamab-gxbm (Columvi) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or
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On May 19, 2023, Epcoritamab-bysp (Epkinly, Genmab US, Inc) was granted accelerated approval by the US FDA for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising
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On May 22, 2023, the U.S. Food and Drug Administration approved avapritinib (Ayvakit) for the treatment of adults with indolent systemic mastocytosis. Avapritinib had previously been approved for advanced systemic mastocytosis in
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