November 16, 2018 / 1:18 PM / a month ago

BRIEF-Novartis Receives Positive CHMP Opinion To Expand Breast Cancer Therapy

Nov 16 (Reuters) - Novartis AG:

* NOVARTIS RECEIVES POSITIVE CHMP OPINION TO EXPAND KISQALI® COMBINATION THERAPY TO ALL WOMEN WITH HR+/HER2- LOCALLY ADVANCED OR METASTATIC BREAST CANCER

* CHMP OPINION IS SUPPORTED BY TWO PIVOTAL PHASE III TRIALS SHOWING CLINICAL BENEFIT OF KISQALI-BASED REGIMENS, REGARDLESS OF COMBINATION PARTNER OR MENOPAUSAL STATUS, AS FIRST OR SECOND-LINE TREATMENT

* KISQALI PLUS FULVESTRANT DEMONSTRATED SUPERIOR EFFICACY IN PATIENTS WITH DE NOVO ADVANCED BREAST CANCER, AND IN THOSE WHO HAD NOT RECEIVED ADJUVANT THERAPY IN MORE THAN A YEAR VERSUS. FULVESTRANT ALONE IN LARGE PHASE III TRIAL POPULATION

* S CHMP OPINION BRINGS US ONE STEP CLOSER TO PROVIDING MORE WOMEN WITH HR+/HER2- ADVANCED BREAST CANCER IN EUROPE WITH A TREATMENT OPTION Source text for Eikon: Further company coverage: (Reporting by Berlin Speed Desk)

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