INDUSTRY NEWS
Industry News
FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer
On November 8, the US Food and Drug Administration (FDA) approved fruquintinib for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
For more information read the FDA announcement .
FDA Approves Pembrolizumab with Chemotherapy for Biliary Tract Cancer
On October 31, the US Food and Drug Administration (FDA) approved pembrolizumab to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.
For more information read the FDA announcement and Merck annoucement .
FDA Approves Toripalimab-tpzi for Nasopharyngeal Carcinoma
On October 27, the US Food and Drug Administration (FDA) approved toripalimab-tpzi in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.
For more information read the FDA announcement and Coherus BioSciences announcement .
FDA Approves Ivosidenib for Myelodysplastic Syndromes
On October 24, the US Food and Drug Administration approved ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test.
For more information read the FDA Announcement .
FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer
On October 20, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to entrectinib for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase 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.
For more information read the FDA announcement .