ASTELLAS PHARMA

Astellas Pharma's VYLOY (zolbetuximab-clzb) gains FDA approval for advanced gastric and gastroesophageal junction cancer treatment, combined with chemotherapy. This marks the first US approval for VYLOY targeting CLDN18.2-positive tumors, identified via Roche's VENTANA CLDN18 assay. Phase III trials SPOTLIGHT and GLOW showed significant PFS and OS improvements in CLDN18.2-positive patients. VYLOY is now approved in five global markets.

Astellas Pharma (JP:4503) received FDA approval for VYLOY, a CLDN18.2-targeting treatment for advanced gastric and gastroesophageal junction cancer, based on successful SPOTLIGHT and GLOW trials. This milestone is expected to positively impact Astellas' financial forecast.

FDA approves VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, in combination with chemotherapy. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved PFS and OS. Common side effects include nausea, vomiting, and decreased appetite.

Roche Holdings received FDA approval for its Ventana CLDN18 (43-14A) RxDx Assay, a companion diagnostic for gastric and gastroesophageal junction cancer, aiding in identifying CLDN18.2 positive tumors and potential eligibility for Astellas Pharma's Vyloy treatment.

Astellas Pharma's VYLOY (zolbetuximab-clzb) approved by FDA for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer, in combination with chemotherapy. Roche's VENTANA CLDN18 (43-14A) RxDx Assay is the first FDA-approved IHC companion diagnostic for identifying eligible patients.

The global CAR-T cell therapy market is expanding, with nine products commercialized and more expected by 2032. CAR-T therapy modifies T-cells to target cancer cells, showing efficacy in blood cancers. Challenges include treatment time, reimbursement, and solid tumor application. The industry focuses on innovation, partnerships, and overcoming these hurdles for future growth.

FDA approves iota Biosciences' EFS for an implantable device to treat underactive bladder via electrical stimulation, with initial enrollment of 3 patients and potential expansion to 10.