The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
No new studies have been requested
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Subscribe To Our Newsletter & Stay Updated
