Novartis: positive CHMP opinion for breast cancer drug
(CercleFinance.com) - Novartis reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for its Kisqali, to reduce the risk of recurrence in women with HR+/HER2- early breast cancer.
The CHMP thus recommends granting marketing authorisation for the product, for the adjuvant treatment of adults at high risk of disease recurrence, including those with node-negative disease.
This recommendation is based on the Phase III NATALEE trial, in which Kisqali combined with endocrine therapy significantly reduced the risk of recurrence by 25% compared with endocrine therapy alone in a large patient population.
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The CHMP thus recommends granting marketing authorisation for the product, for the adjuvant treatment of adults at high risk of disease recurrence, including those with node-negative disease.
This recommendation is based on the Phase III NATALEE trial, in which Kisqali combined with endocrine therapy significantly reduced the risk of recurrence by 25% compared with endocrine therapy alone in a large patient population.
Copyright (c) 2024 CercleFinance.com. All rights reserved.