CHMP
CHMP Recommends Approval of J&J's Subcutaneous Rybrevant for Certain NSCLC Patients in Europe
The committee recommended the new formulation in two EGFR-mutated advanced NSCLC settings, for which intravenous Rybrevant is already available.
CHMP Issues Positive Opinion for BMS's Breyanzi in Third-Line Follicular Lymphoma
The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.
CHMP Recommends European Approval for AstraZeneca, Daiichi Sankyo's Datroway in Breast Cancer
The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
European Commission Approves AstraZeneca's Tagrisso in Unresectable EGFR-Mutated NSCLC
Tagrisso is the first targeted therapy for European patients with unresectable EGFR-mutated lung cancer.
Krystal Biotech Expects CHMP Opinion on Skin Condition Gene Therapy in Early 2025
The firm is on track to launch the gene therapy for dystrophic epidermolysis bullosa, called Vyjuvek in the US, in Germany in Q2 2025.