European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer

Benzinga10-19

On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib). ...

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0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEuropean Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-10-19 01:37 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/european-medicines-agencys-panel-supports-173708863.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib).\n...</p>\n\n<a href=\"https://finance.yahoo.com/news/european-medicines-agencys-panel-supports-173708863.html\">Source 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epidermal growth factor receptor 2-negative  early breast cancer , at high risk of disease recurrence, including those with node-negative disease.Also Read: Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts.The CHMP decision is based on data from the Phase 3 NATALEE trial.In the trial, Kisqali plus endocrine therapy , compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC.The data also demonstrated a consistent, clinically meaningful invasive disease-free survival  benefit across key pre-specified subgroups.Data from the pivotal trial also showed that the safety profile of Kisqali at the 400mg","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4532":"文艺复兴科技持仓","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) 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Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib).\nThe CHMP recommended approval granting marketing authorization for Kisqali (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease.\nAlso Read: Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts.\nThe CHMP decision is based on data from the Phase 3 NATALEE trial.\nIn the trial, Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC.\nThe data also demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.\nData from the pivotal trial also showed that the safety profile of Kisqali at the 400mg dose was well-tolerated, with generally low-grade symptomatic adverse events.\nThe European Commission (EC) will decide in approximately two months.\nLast month, Novartis released new data from the ALITHIOS open-label extension study.\nData show first-line Kesimpta (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from Sanofi SA‘s Aubagio (teriflunomide).\nPrice Action: NVS stock is up 0.35% at $116.92 at last check Friday.\nPhoto via Shutterstock\nRead Next:\n\nWhat’s Going On With TreeHouse Foods Stock Today?\n\nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nNOVARTIS (NVS): Free Stock Analysis Report\n\nThis article European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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