The FDA handed Gossamer Bio, a biotech company, a partial clinical hold after two patients died in its BTK inhibitor trial, EndPoints News reported April 3.
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 of Gossamer Bio, told EndPoints News.
The biotech company is terminating all studies and development of the drug at this time, according to the report.