- In April 2023, Gossamer Bio announced the initiation of a Phase 1b/2 clinical trial for GB5121, an oral, CNS-penetrant Bruton's tyrosine kinase (BTK) inhibitor, targeting primary central nervous system lymphoma (PCNSL)
- In April 2023, Gossamer Bio announced the termination of all ongoing studies and the discontinuation of GB5121 development due to the FDA's partial clinical hold and the observed adverse events
- In March 2023, Gossamer Bio received a partial clinical hold from the U.S. FDA on all trials of GB5121 following serious adverse events, including a fatal intracranial hemorrhage, observed in the Phase 1b/2 STAR-CNS study
- In July 2022, Pfizer Inc. gained U.S. FDA approval for Xalkori (crizotinib) to treat pediatric and adult patients with ALK-positive inflammatory myofibroblastic tumor (IMT). For adult patients, the recommended dosage is 250 mg, administered orally twice daily until disease progression halts. This approval is anticipated to drive growth in the oral treatment segment
- In October 2021, Gossamer Bio, Inc., a clinical-stage biotechnology company, announced the addition of two CNS-penetrant Bruton's tyrosine kinase (BTK) inhibitors to its product candidate portfolio. The company focuses on discovering, acquiring, developing, and commercializing treatments for conditions related to inflammation, immunology, and cancer. The first of these candidates, GB5121, entered first-in-human clinical trials in the fourth quarter of 2021
