DAIICHI SANKYO, INC.

FDA approved Astellas’ Vyloy for gastric cancer, available in 6-12 business days at $1600/100mg vial. Vyloy, first targeted therapy for specific protein family in gastric cancers, was previously approved in Japan and UK. Roche’s companion diagnostic test also approved to identify eligible patients.

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.

The WSG-TP-II trial (NCT03272477) explored de-escalation of neoadjuvant endocrine therapy plus trastuzumab and pertuzumab in HR-positive, HER2-positive early breast cancer. Conducted in Germany, it compared 12 weeks of endocrine therapy or paclitaxel with trastuzumab and pertuzumab, followed by 1 year of adjuvant therapy. The trial found this regimen safe for chemotherapy de-escalation.

Diabetic Peripheral Neuropathy market to surge due to increasing prevalence and awareness, with multiple-stage pipeline products revolutionizing market dynamics. Key companies include Grünenthal, Averitas Pharma, Daiichi Sankyo, Vertex Pharmaceuticals, Helixmith, and Lexicon Pharmaceuticals. Emerging therapies such as QUTENZA (capsaicin) and TARLIGE (mirogabalin besylate) are expected to drive market growth.

Daiichi Sankyo and AstraZeneca's ENHERTU receives conditional approval from China's NMPA for treating unresectable or metastatic NSCLC with HER2 mutations, marking the fourth approval in China for ENHERTU across different tumor types. The approval is based on Phase II studies DESTINY-Lung02 and DESTINY-Lung05, showing ORRs of 49% and 58.3% respectively.

AstraZeneca and Daiichi Sankyo's Enhertu received conditional approval in China for treating HER2-mutant metastatic NSCLC, based on DESTINY-Lung02 and DESTINY-Lung05 trials. Enhertu demonstrated a confirmed objective response rate of 49.0% in DESTINY-Lung02 and 58.3% in DESTINY-Lung05, with no new safety concerns. This marks the first HER2-directed therapy approved in China for this indication.