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CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer
Levi Garraway Global Product Development At Roche European Union European Commission European Medicines Agency Medicinal Products

Momelotinib Approaches EU Approval for Myelofibrosis With Anemia

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.
Nina Mojas Dynamic International Prognostic Scoring System European Union European Medicines Agency Medicinal Products Human Use

CHMP Recommends Adagrasib for Pretreated KRAS G12C+ Advanced NSCLC

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.
Schleswig Holstein Alan Sandler Martin Reck Adagrasib Krazati European Commission European Union

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