Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance for Priority Review of Enhertu to Treat HER2 Mutant Metastatic Non-Small Cell Lung Cancer
Shots:
- The sBLA is based on P-II (DESTINY-Lung01) trial evaluating Enhertu (6.4 mg/kg) in ~180 patients with HER2 mutant or HER2 overexpressing unresectable & metastatic nonsq. NSCLC at multiple sites including Asia, EU & North America. The US FDA’s decision is expected in Q2’22
- The results showed a strong & robust tumor response in 50% of patients, ORR (54.9%). Out of 91 patients, 1 (1.1%) CR & 49 (53.8%) PR, DCR (92.3%) with a reduction in tumor size, m-DoR (9.3mos.) after a median follow-up of 13.1mos., m-PFS (8.2mos.) & m-OS (17.8mo.), 23 (25%) discontinued due to drug-related TEAEs
- The therapy was approved in multiple countries for HER2+ GC or GEJ adenocarcinoma, based on (DESTINY-Gastric01) trial
Ref: Businesswire | Image: Daiichi Sankyo
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