By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY The U.S. Food and Drug Administration granted accelerated approval for Pirtobrutinib (Jaypirca) to be administered to adult patients diagnosed with chronic lymphocytic leukemia (CLL) or small
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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On April 19, 2023, the U.S. Food and Drug Administration (FDA) approved Polatuzumab Vedotin-Piiq in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients with previously untreated diffuse
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On April 3, 2023, the U.S. Food and Drug Administration approved enfortumab vedontin-ejfv with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy and
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On March 29, 2023, the U.S. Food and Drug Administration approved pembrolizumab for adult and pediatric patients with unresectable or metastatic solid cancers with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
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On March 22, 2023, the U.S. Food and Drug Administration granted accelerated approval to retifanlimab-dlwr — a humanized monoclonal antibody that targets human PD-1 — for adult patients with metastatic or recurrent
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On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib and trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation
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On March 4, 2023, the U.S. Food and Drug Administration approved expanded use of adjuvant abemaciclib with endocrine therapy for adult patients with early, hormone receptor (HR)-positive, human epidermal growth factor receptor
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On February 9th, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly for adult patients with recurrent or advanced endometrial cancer (EC) with mismatch repair deficiency (dMMR) determined by an FDA-approved test,
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On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with HR+/HER2-Metastatic Breast Cancer refractory to or relapsed after at least 2, and
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