News and analysis on disease research and diagnostics.
Researchers showed that ctDNA levels predicted who would respond to first-line immune checkpoint inhibition but were not useful in second-line therapy.
The company's aim in the Beat AML subprotocol is to determine the safety, maximum tolerated dose, and response rate with dubermatinib and chemotherapy.
Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.
The results demonstrated the safety and preliminary efficacy of bispecific, anti-CD19, anti-CD20 CAR T-cell therapy for patients with B-cell cancers.
The agency made the recommendation based on data showing that Keytruda improved outcomes and was cost-effective compared to the standard treatment.
