Tag Archive for: gastric cancer

Japan’s Astellas Pharma said the agency declined to approve its experimental drug to treat a type of gastric cancer, citing issues related to a third-party manufacturer.

The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Merck & Co. said on Tuesday its blockbuster immunotherapy Keytruda failed to meet one of the two main goals in a late-stage study testing it as a treatment option for a type of advanced gastric cancer.

Chinese drug developer BeiGene said on Thursday its experimental drug helped extend lives of patients with a type of gastric cancer in a late-stage trial.

The FDA has set a Feb. 9 meeting for its Oncologic Drugs Advisory Committee (ODAC) to discuss whether GSK’s clinical development plans for Jemperli (dostarlimab) could support accelerated approval.

The buyout will grant Leap Therapeutics access to Flame Bioscience’s portfolio, which includes a clinical-stage monoclonal antibody that is under investigation as a potential treatment for gastric, gastroesophageal junction, and pancreatic cancers.

The company said its therapy involving cancer drug Keytruda in combination with chemotherapy met the main goal of a late-stage study for treating a type of gastric cancer.

Astellas’s Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.

AstraZeneca said a late-stage trial had confirmed the benefit of breast cancer drug Enhertu in patients with an advanced form of the disease who had been previously treated with another therapy.

At the American Society of Clinical Oncology (ASCO)’s annual meeting this weekend, BioNTech and Dr. Vinod Balachandran, M.D. of Memorial Sloan Kettering Cancer Center, presented preliminary Phase I data of its BNT122, which it is evaluating with Genentech (Roche) in pancreatic cancer.