EMA’s CHMP Issues Negative Opinion of Neratinib as Added Therapy in Early Stage HER2-positive Breast Cancer

EMA’s CHMP Issues Negative Opinion of Neratinib as Added Therapy in Early Stage HER2-positive Breast Cancer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion of neratinib as an extended adjuvant treatment of early stage, HER-2 positive breast cancer. The negative opinion means the committee recommends the EMA reject a marketing application for neratinib for this indication as submitted by its developer, Puma Biotechnology. Adjuvant therapies are used as an addition to primary treatment to help further decrease the risk of cancer returning in these patients. The committee's decision contrasts that of the U.S. Food and Drug Administration, which approved the medicine for this indication in July 2017. The therapy is sold as Nerlynx tablets. Puma Biotechnology had announced in January that the CHMP was unlikely to recommend neratinib for this indication, following a meeting between company officials and members of the CHMP. Puma can request the decision be reevaluated if it does so within 15 days of the receipt of the CHMP decision. The company said it would submit a letter of intent by that deadline. The negative opinion was based on results from two trials, the Phase 2 CONTROL trial (NCT02400476) and the Phase 3 ExteNET trial (NCT00878709). ExteNET, a double-blind, placebo-controlled study, randomized 2,840 patients to receive ne
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