FDA approved

FDA approves niraparib and abiraterone acetate plus prednisone for metastatic prostate cancer With BRCA Mutation

By Dr. Anish Shah Bronx Lebanon Hospital   On August 11, 2023, the U.S. Food and Drug Administration granted regular…

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 Approves Dabrafenib with Trametinib for Pediatric Patients with Low-Grade Glioma (LGG), a BRAF V600E Mutation

On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib and trametinib for pediatric patients 1 year of…

2 years ago

FDA Approves an Expanded Indication of Abemaciclib with Endocrine Therapy for Early Breast Cancer

On March 4, 2023, the U.S. Food and Drug Administration approved expanded use of adjuvant abemaciclib with endocrine therapy for…

2 years ago

FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer

On February 9th, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly for adult patients with recurrent or advanced endometrial…

2 years ago

FDA Approves Pemigatinib in Patients with Relapsed/Refractory Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement: Finally a Treatment Option for a Challenging Disease

By Dr. Abhishek A. Mangaonkar Mayo Clinic   The phase 2 FIGHT-203 trial (NCT#03011372) studied 28 patients with relapsed/refractory myeloid/lymphoid…

2 years ago

FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with…

2 years ago

FDA approves Elacestrant for ER-positive, HER2-negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant for postmenopausal, non-pregnant women and adult men with…

2 years ago

FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

On January 27, 2023, the U.S. Food and Drug Administration approved Pirtobrutinib for adult patients with histologically confirmed relapsed or…

2 years ago