News | March 25, 2022
CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
Recommendation is based on pivotal data from the phase III POLARIX study
Recommendation is based on pivotal data from the phase III POLARIX study
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
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