Drug Approval | December 20, 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Positive opinions based on significant survival benefit
Positive opinions based on significant survival benefit
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
First and only PARP inhibitor to improve invasive disease-free survival in patients
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients
Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU
If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe
With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients
Subscribe To Our Newsletter & Stay Updated
_256_275.jpg)