FDA Halts Cancer Drug Trial After The Death of 2 Patient
According to, EndPoints News the FDA has handed Gossamer Bio, a biotech company, a partial clinical hold after two patients died in its BTK inhibitor trial. The hold was placed on the oral lymphoma drug trial after serious adverse events, including atrial fibrillation, a sudden death event, and a fatal intracranial hemorrhage, according to a Securities and Exchange Commission filing.
The death event and fatal hemorrhage occurred in two different patients with central nervous system lymphoma, Bryan Giraudo, finance, and operating chief, told Endpoints News. Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutics in the disease areas of immunology, inflammation, and oncology. The biotech company is terminating all studies and development of the drug at this time, according to the report