Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.
FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).
Lindis Biotech GmbH announced a licensing agreement with global pharmaceutical company Pharmanovia for catumaxomab, for the treatment of malignant ascites.
FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
The European Commission approved Vyloy (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.
A study recently published in JAMA sheds light on cancer risks associated with carrying germline CDH1 mutations, challenging previous, potentially inflated, lifetime cancer risk estimates.
The European Medicines Agency’s Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion of zolbetuximab, recommending the approval of it in the European Union.
Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
