Astellas Pharma's VYLOY Receives FDA Approval For Treatment Of …
11 hours ago · VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive.
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer …
1 day ago · In the 565-patient SPOTLIGHT study, patients on Vyloy plus chemotherapy achieved median progression-free-survival (PFS) of 10.6 months, compared with 8.7 months in the group that received placebo ...
Vyloy Approved for Gastric and Gastroesophageal Junction Cancer
1 day ago · Vyloy is a chimeric IgG1 monoclonal antibody that binds to CLDN18.2 on the cancer cell surface of gastric epithelial cells. This action results in antibody-dependent cellular cytotoxicity and ...
FDA Approves Astellas' Vyloy, Chemo in First-Line CLDN18.2 …
1 day ago · The SPOTLIGHT trial explored Vyloy with the fluoropyrimidine-containing chemo mFOLFOX6 versus mFOLFOX6 chemo alone. The median progression-free survival was 10.6 months in the Vyloy arm and 8.7 months in the chemo-only arm. Median overall survival was 18.2 months on Vyloy-chemo versus 15.5 months on chemo alone.
Astellas Pharma's Cancer Drug Vyloy Gets FDA Approval
1 day ago · Vyloy is intended for the first-line treatment of patients whose tumors are claudin (CLDN) 18.2 positive, Astellas said. ... Dow Jones Newswires is a market-moving financial and business news ...
Astellas Receives Approval from the European Commission for VYLOY …
Sep 20, 2024 · Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission (EC) has approved VYLOY™ (zolbetuximab) in combination with...
Astellas' VYLOY™ (zolbetuximab) Approved in Japan for …
Mar 26, 2024 · VYLOY™ (zolbetuximab) is an anti-claudin 18.2 (CLDN18.2) monoclonal antibody that is approved by Japan's Ministry of Health, Labour and Welfare (MHLW) for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer.
News | Astellas Pharma Inc.
Mar 26, 2024 · VYLOY approved in combination with chemotherapy for patients with human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. MHLW approval makes VYLOY the first and only CLDN18.2-targeted therapy approved in the world.
FDA Acknowledges BLA of Zolbetuximab in HER2–, CLDN18.2
May 31, 2024 · The FDA has acknowledged the resubmitted biologics license application (BLA) for zolbetuximab (Vyloy) as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.
News | Astellas Pharma Inc.
May 30, 2024 · News from Astellas. Latest and past news available. TOKYO, May 30, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S.