FDA Approves Vyloy for Advanced Gastric or Gastroesophageal Junction Cancer

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 23, 2024.

By Lori Solomon HealthDay Reporter

WEDNESDAY, Oct. 23, 2024 -- The U.S. Food and Drug Administration has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2-positive as determined by an FDA-approved test.

Vyloy becomes the first and only CLDN18.2-targeted therapy approved in the United States.

The approval is based on the phase 3 SPOTLIGHT and GLOW clinical trials, in which approximately 38 percent of screened patients had tumors that were CLDN18.2-positive (defined as ≥75 percent of tumor cells demonstrating moderate-to-strong membranous CLDN18 immunohistochemical staining), as determined by the Ventana CLDN18 (43-14A) RxDx Assay (Roche). Both the SPOTLIGHT study (Vyloy plus the combination mFOLFOX6 chemotherapy regimen of oxaliplatin, leucovorin, and fluorouracil versus placebo plus mFOLFOX6) and the GLOW study (Vyloy plus the combination CAPOX chemotherapy regimen of capecitabine and oxaliplatin versus placebo plus CAPOX) met their primary end point of progression-free survival. Both studies also met the key secondary end point of overall survival for patients treated with Vyloy plus chemotherapy. The most common all-grade treatment-emergent adverse events reported in the Vyloy treatment arms of the trials were nausea, vomiting, and decreased appetite.

"While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients," Samuel J. Klempner, M.D., from Massachusetts General Hospital in Boston, said in a statement.

Approval of Vyloy was granted to Astellas Pharma.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-10-24 06:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords