Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review
Pneumococcal Vaccine & Four New Drugs Also Up For CHMP Opinion
Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.
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Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.
EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.
The sponsor of an ophthalmic formulation of bevacizumab is set to speak up for its marketing authorization application during a European Medicines Agency oral explanation meeting.