New Drug Applications

FDA grants approval to Pralsetinib for NSCLC With RET Fusion Mutation

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 9, 2023, the U.S. Food and Drug Administration granted regular approval…

1 year ago

FDA Approves Dostarlimab-gxly for Endometrial Cancer With dMMR or MSI-H Mutation

On July 31, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) for primary advanced or recurrent endometrial…

1 year ago

FDA Approves Trifluridine and Tipiracil with Bevacizumab for Metastatic Colorectal Cancer (mCRC) with Specific Mutation

On August 2, 2023, the U.S. Food and Drug Administration approved trifluridine and tipiracil (LONSURF) with bevacizumab for the treatment…

1 year ago

FDA Approves Talazoparib and Enzalutamide for Metastatic Castration-Resistant Prostate Cancer with HRR Gene Mutation

On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) in combination with enzalutamide for…

1 year ago

FDA Approves Quizartinib (Vanflyta) for Acute Myeloid Leukemia With FLT3-ITD Mutation

On July 20, 2023, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta) for adult patients newly diagnosed with…

1 year ago

FDA Grants Accelerated Approval to Glofitamab-gxbm for Relapsed/Refractory DLBCL

On June 15, 2023, the U.S. Food and Drug Administration approved Glofitamab-gxbm (Columvi) for the treatment of adult patients with…

1 year ago

FDA Grants Accelerated Approval to Epcoritamab for Relapsed or Refractory Diffuse Large B-cell Lymphoma and High-Grade B-cell Lymphoma

On May 19, 2023, Epcoritamab-bysp (Epkinly, Genmab US, Inc) was granted accelerated approval by the US FDA for the treatment…

1 year ago

FDA Grants Approval to Avapritinib for Indolent Systemic Mastocytosis

On May 22, 2023, the U.S. Food and Drug Administration approved avapritinib (Ayvakit) for the treatment of adults with indolent…

1 year ago

FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Large B-cell Lymphoma

On April 19, 2023, the U.S. Food and Drug Administration (FDA) approved Polatuzumab Vedotin-Piiq in combination with a rituximab product,…

2 years ago

FDA Approves Enfortumab Vedotin with Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

On April 3, 2023, the U.S. Food and Drug Administration approved enfortumab vedontin-ejfv with pembrolizumab for patients with locally advanced…

2 years ago