New Approvals
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
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
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
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,
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
On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant for postmenopausal, non-pregnant women and adult men with advanced or metastatic ER-positive HER-2 negative breast cancer. Patients must have received
On January 27, 2023, the U.S. Food and Drug Administration approved Pirtobrutinib for adult patients with histologically confirmed relapsed or refractory Mantle cell lymphoma intolerant to two or more standard therapies, one
FDA Approves Pembrolizumab as Adjuvant therapy for Early-stage Resectable Non-small Cell Lung Cancer
On January 26, 2023, the U.S. Food and Drug Administration approved Pembrolizumab for patients with resectable, stage IB (≥4cm)-IIIA (as per the AJCC 7th Edition Staging System) non-small cell lung cancer after
On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to Tucatinib plus Trastuzumab for adult patients with RAS wild-type metastatic colon cancer with HER2-positive status as detected at