Oct. 24, 2024 – The FDA has approved a brand new drug called zolbetuximab that's designed to attack a novel goal in a form of stomach cancer.
The drug, marketed under the brand name Vyloy, is meant for use together with fluoropyrimidine- and platinum-based chemotherapy in adults with advanced cancer of the stomach or gastroesophageal junction (GEJ) that's positive for claudin 18.2 (CLDN18.2), a protein that promotes tumor growth and spread. Vyloy is the primary drug within the United States to focus on this protein.
“While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in recent years, there is still a tremendous unmet need in our patients,” says Samuel J. Klempner, MD, a cancer specialist at Massachusetts General Hospital, Boston, and associate professor at Harvard Medical School, said in a opinion. The approval “brings a novel biomarker and therapy to patients with CLDN18.2-positive tumors and to those at the forefront of treatment decisions.”
The treatment is meant for patients with HER2-negative gastric or GEJ adenocarcinoma that has either spread or can't be removed surgically. In clinical trials, roughly 38% of those patients were found to be CLDN18.2 positive. The FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay, a test to detect CLDN18.2-positive tumors and make sure eligibility for the brand new treatment.
The approval was based on the outcomes of two international phase III clinical trials involving 567 and 507 patients. In the studies, Vyloy was added to 2 different chemotherapy regimens.
In one study, patients who took Vyloy with chemotherapy had no worsening of their cancer for 10.6 months, in comparison with 8.7 months for patients who took a placebo. The addition of Vyloy also improved overall survival by about three months. Patients in the opposite study with chemotherapy saw similar results – those on Vyloy stayed 8.2 months without their cancer worsening, in comparison with 6.8 months with chemotherapy alone. The overall survival profit was roughly two months.
The FDA reported similar unwanted side effects in each studies. Common unwanted side effects included nausea and vomiting, decreased appetite, diarrhea, pneumonia and fever. The drug's manufacturer, Astellas, warned of great allergic and infusion-related reactions and added a warning for ladies to avoid breastfeeding while taking Vyloy and for eight months after the last dose.