1/5/2024 0 Comments Orbis clinical trialA treatment (Fyarro) for locally advanced unresectable or metastatic perivascular epithelioid cell tumor (PEComa), a group of rare tumors that form in the soft tissues of the stomach, intestines, lungs and other body parts.A therapy (Darzalex Faspro) to be used together with other treatments for light chain amyloidosis, a cancer occurring when an abnormal protein builds up in the organs.A therapy (Welireg) for use in adults to treat certain tumors that are associated with von Hippel-Lindau disease an inherited disorder characterized by tumors and cysts. Two treatments (Truseltiq and Tibsovo) for adults with certain kinds of cholangiocarcinoma, a group of aggressive cancers that start in the bile duct.Other approvals for rare cancers included: Also related to stomach and esophageal cancer, OOD approved two other therapies (Enhertu and Keytruda) for certain patients with HER2-positive gastric cancer and GEJ adenocarcinoma, one of which (Keytruda) also was approved for esophageal cancer, advanced kidney cancer, and as an add-on treatment for kidney cancer.Īdditionally, OOD approved Keytruda for early-stage, triple negative breast cancer, or cancer that does not respond to hormonal therapies or medications that target HER2 protein receptors. OOD also approved the first immunotherapy (Opdivo), or therapy that stimulates or suppresses the immune system, as a first-line treatment for esophageal (esophagus-related) cancer, gastric (stomach) cancer, and gastroesophageal junction (GEJ) adenocarcinoma, a rare cancer that starts where the esophagus and stomach join together. The Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) approved four new drugs for non-small lung cancer (Tepmetko, Rybrevant, Lumakras, Exkivity), including one non-small cell lung cancer type previously thought to be resistant to treatment.įor skin cancer, OOD approved a therapy (Libtayo) for some types of basal cell carcinoma, the most common form of `skin cancer, for certain patient populations. The OCE collaborates with the three FDA product centers reviewing drugs, biologic therapies, and devices to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
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