New Approvals
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On November 16, 2023, the U.S. Food and Drug Administration approved Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy as the first line treatment for adults with
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On the date of approval, the U.S. Food and Drug Administration approved Nirogacestat (Ogsiveo) for adult patients with progressing desmoid tumors who require systemic treatment. This
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On November 16, 2023, the U.S. Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) in combination with Fulvestrant for adult patients with hormone receptor
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 October 11, 2023, the U.S. Food and Drug Administration granted approval to Encorafenib (BRAF inhibitor) with Binimetinib (MEK inhibitor) for patients with metastatic non-small cell lung cancer (NSCLC) that was detected
On September 26, the U.S. Food and Drug Administration expanded the approval of bosutinib (Bosulif) to include pediatric patients 1 year of age and older. Previously, bosutinib had been approved for adults
By Dr. Anish Shah Bronx-Lebanon Hospital On August 14, 2023, the U.S. Food and Drug Administration approved HEPZATO KIT – which is melphalan, as a liver-directed treatment for adult patients with
By Dr. Anish Shah Bronx-Lebanon Hospital On August 14, 2023, the U.S. Food and Drug Administration granted accelerated approval to Elranatamab-bcmm (Elrexfio) for adults with relapsed or refractory multiple myeloma who
By Dr. Anish Shah Bronx Lebanon Hospital On August 11, 2023, the U.S. Food and Drug Administration granted regular approval to niraparib and abiraterone acetate (Akeega) plus prednisone for adult patients
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