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
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
New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
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