Ribociclib

Ribociclib (Kisqali) plus aromatase inhibitor recommended for HR+/HER2- early breast cancer, based on NATALEE trial and FDA approval. Kisqali is the only Category 1 CDK4/6 inhibitor for first-line treatment of HR+/HER2- metastatic breast cancer.

A global clinical trial involving local participants led to FDA approval of a new drug for early breast cancer treatment. The NATALEE trial, with 14 local patients among 5,100 participants from 20 countries, showed a 25.1% reduction in recurrence risk for HR+/HER2- stage II and III early breast cancer patients receiving adjuvant Kisqali alongside endocrine therapy. Local patient Valerie Derrick, diagnosed with stage 3 breast cancer, participated in the trial and has been off the drug for two years with no recurrence.

CHMP recommended approval of Novartis' Kisqali for HR+/HER2- early breast cancer, based on NATALEE study data showing a 25.1% reduction in recurrence risk. Kisqali's safety profile was well-tolerated, and the EC will decide within two months. Kisqali could double eligible patients for CDK4/6 inhibitor therapy.

EMA’s CHMP recommends marketing authorisation for Kisqali (ribociclib) as adjuvant treatment for HR+/HER2- early breast cancer patients at high risk of recurrence, based on NATALEE trial results showing a 25.1% reduction in cancer recurrence risk with Kisqali plus endocrine therapy compared to ET alone. The recommendation extends to node-negative disease patients, with a well-tolerated safety profile at 400mg dosage.

EMA's CHMP recommended 10 new medicines for approval, including vaccines Fluad and Flucelax for influenza, and extensions for 6 drugs. Biosimilars Absimky and Imuldosa, and generic Eltrombopag Viatris were also recommended. CHMP maintained its refusal for Masitinib AB Science and withdrew applications for Apremilast Viatris and Epixram.

The CHMP of the EMA recommended marketing authorization for Kisqali (ribociclib) for adjuvant treatment of HR+/HER2- early breast cancer at high risk of recurrence, based on the NATALEE trial data showing a 25.1% reduction in recurrence risk. Kisqali, if approved, could expand treatment options for patients, including those with node-negative disease.

CHMP recommends Kisqali for adjuvant treatment of HR+/HER2- early breast cancer in Europe, based on NATALEE trial data showing 25% reduction in recurrence risk with Kisqali plus endocrine therapy versus endocrine therapy alone.

The European Medicines Agency's CHMP recommended 10 new medicines for approval, including vaccines Fluad and Flucelax for influenza, and extensions for six drugs. Two biosimilars and two generic drugs were also approved. CHMP confirmed its refusal of Masitinib AB Science for amyotrophic lateral sclerosis and withdrew consideration for Apremilast Viatris and Epixram due to data issues and regulatory strategy changes, respectively.