DAIICHI SANKYO, INC.

Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.

Thermo Fisher's Oncomine receives FDA approval as companion diagnostic for grade 2 IDH-mutant glioma, identifying patients eligible for Servier's Voranigo treatment. Voranigo, a once-daily IDH1/IDH2 inhibitor, is the first targeted therapy for this condition, with projected sales of $37m by 2030.

Thermo Fisher Scientific's Oncomine gains FDA approval as a companion diagnostic for grade 2 IDH-mutant glioma, identifying patients eligible for Servier Pharmaceuticals' Voranigo treatment. Voranigo, a once-daily IDH1/IDH2 inhibitor, is the first targeted therapy for this condition.

FDA approves Astellas' Vyloy therapy for gastric cancer, available in 6-12 business days at $1600 per 100 mg vial. Vyloy, a monoclonal antibody, improves survival in late-stage trials and is the first targeted therapy for a specific protein family in gastric cancers.

Gilead is withdrawing Trodelvy from the market in bladder cancer after the TROPiCS-04 trial failed to meet its primary endpoint. Trodelvy remains on the market for other indications, including advanced breast cancer. The withdrawal does not affect its traditional approvals in different types of advanced breast cancer. Gilead intends to report full TROPiCS-04 trial results at an upcoming medical meeting.

Gilead withdraws Trodelvy for bladder cancer after negative trial results, impacting less than 10% of sales; focuses on breast cancer, with $1 billion sales forecast by 2030; faces challenges in lung cancer expansion; awaits Phase 3 trial data for triple-negative breast cancer.

Breast cancer patients denied Enhertu, a life-extending drug, due to cost concerns by NICE, despite its availability in 19 European countries. Jeannie Ambrose, one of 1,000 affected, argues for its NHS funding, hoping for extra time with her family.

Advances in precision medicine have transformed NSCLC treatment, with broad molecular testing now recommended. HER2 mutation, present in 3% of NSCLC patients, is associated with aggressive disease and brain metastases. No first-line HER2-targeted therapies are approved; current options include immunotherapy and platinum doublet. Zongertinib and BAY 2927088, oral HER2-targeted TKIs, show promise in pre-treated patients, with zongertinib demonstrating a 66.7% ORR and BAY 2927088 showing a 72.1% ORR. Both agents have been granted breakthrough therapy designation by the FDA.

AstraZeneca and Daiichi Sankyo's Enhertu receives conditional approval in China for treating HER2-mutant NSCLC, based on DESTINY-Lung02 and DESTINY-Lung05 trials. Full approval pending confirmatory trial results.