The FDA on November 7, 2023, revised the existing indication of KEYTRUDA® (Pembrolizumab) with Trastuzumab, Fluoropyrimidine, and Platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test. KEYTRUDA® is a product of MERCK & Co., Inc.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on October 31, 2023, approved KEYTRUDA® to be used with Gemcitabine and Cisplatin for locally advanced unresectable or metastatic Biliary Tract Cancer (BTC). KEYTRUDA® is a product of Merck & Co., Inc.
LOQTORZ® (Toripalimab-tpzi)
The FDA on October 27, 2023, approved LOQTORZ® (Toripalimab-tpzi) with Cisplatin and Gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced Nasopharyngeal carcinoma. The FDA also approved LOQTORZ® as a single agent for adults with recurrent unresectable or metastatic Nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy. LOQTORZ® is a product of Coherus BioSciences, Inc.
TIBSOVO® (Ivosidenib)
The FDA on October 24, 2023, approved TIBSOVO® for adult patients with Relapsed or Refractory MyeloDysplastic Syndromes (MDS) with a susceptible Isocitrate DeHydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. TIBSOVO® is a product of Servier Pharmaceuticals LLC.
ROZLYTREK® (Entrectinib)
The FDA on October 20, 2023, granted accelerated approval to ROZLYTREK® for pediatric patients older than 1 month with solid tumors that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to ROZLYTREK® for pediatric patients 12 years of age and older for this indication. ROZLYTREK® is a product of Genentech Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on October 16, 2023, approved KEYTRUDA® with Platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent KEYTRUDA® as post-surgical adjuvant treatment for resectable (tumors 4 cm or more, or node positive) Non-Small Cell Lung Cancer (NSCLC). KEYTRUDA® is a product of Merck & Co., Inc.
BRAFTOVI® (Encorafenib) and MEKTOVI® (Binimetinib)
The FDA on October 11, 2023, approved BRAFTOVI® with MEKTOVI® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Both BRAFTOVI® and MEKTOVI® are products of Array BioPharma Inc., a wholly owned subsidiary of Pfizer.
BOSULIF® (Bosutinib)
The FDA on September 26, 2023, approved BOSULIF® for pediatric patients 1 year of age and older with Chronic Phase (CP) Ph+ Chronic Myelogenous Leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg. BOSULIF® is a product of Pfizer.
TEMODAR® (Temozolomide)
The FDA on September 14, 2023, approved updated labeling for TEMODAR® under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was XELODA® (Capecitabine). TEMODAR® is a product of Merck & Co., Inc..