First and only PARP inhibitor to improve invasive disease-free survival in patients
V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019
LYNPARZA is approved in the U.S. for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations)
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Based on a post hoc analysis, fewer required respiratory interventions
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
Among patients with infectious virus at baseline, no patients who received Lagevrio had infectious virus at days 3, 5 or 10
No new studies have been requested
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
At the interim analysis, the combination of Keytruda and Lynparza did not demonstrate a benefit in overall survival (OS), one of the study’s dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide
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