EMA's CHMP backs four new medicines at May meeting

At its May meeting, EMA’s CHMP backed four new medicines for ER+/HER2- breast cancer, rare PIK3CA-related overgrowth spectrum disorders, pulmonary fibrosis and glabellar lines. Among 11 recommended label extensions was the oral formulation of Wegovy semaglutide for obesity.

CHMP recommended approval of the oral selective estrogen receptor degrader (SERD) Etcamah camizestrant from AstraZeneca plc (LSE:AZN; NYSE:AZN), in combination with a CDK4/6 inhibitor, for ER+/HER2- ESR1-mutant advanced or metastatic breast cancer without disease progression during first-line endocrine therapy. Should the European Commission approve the drug, it would be the first oral SERD marketed as first-line treatment. ...