Novartis Adjusts Manufacturing of Breast Cancer Drug Ribociclib
By Pierre Bertrand
Novartis said it is making manufacturing adjustments for its cancer drug ribociclib and has paused taking on new patients in studies involving the treatment in order to ensure it meets the latest regulatory guidance.
The adjustments are being made to meet new early-breast-cancer treatment standards by the end of the second quarter, following regulatory guidance on the intake of nitrosamines in medications, the Swiss pharmaceutical company said late Tuesday.
Nitrosamines are chemicals classed as probable carcinogens in humans, according to the European Medicines Agency's website.
Novartis said the change doesn't affect patient use or commercial supply of Kisqali, the brand name for the cancer treatment, which is approved for metastatic breast cancer.
The company has paused the enrollment of new patients in studies involving the drug for early breast cancer, it said.
Regulatory review of ribociclib for the treatment early breast cancer is expected to proceed as planned, Novartis said.
Write to Pierre Bertrand at pierre.bertrand@wsj.com
(END) Dow Jones Newswires
April 10, 2024 02:02 ET (06:02 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
Six Sports Betting and iGaming Stocks Trading at a Discount
-
4 Predictions for Stocks and the Economy for the Second Half of 2024
-
What Broadening Rally? AI Stocks Dominate Again In Q2
-
After Earnings, Is Nike Stock a Buy, a Sell, or Fairly Valued?
-
Worst-Performing Stock ETFs of the Quarter
-
Top-Performing Stock ETFs of the Quarter
-
Q2 In Review and Q3 2024 Market Outlook
-
5 Stocks to Buy for 3Q 2024
-
Industrials: Sector Offers Investment Opportunities as Performance Lags Broader Market
-
Consumer Defensives: Even Amid Macro Pressures, Deals Permeate the Landscape
-
33 Undervalued Stocks
-
Utilities: Can the Stocks Keep the Rally Going?
-
Basic Materials: Following Index Decline, We See Many Long-Term Opportunities
-
Healthcare: Valuations Look Attractive In Most Industries
-
Financial Services: Amid Uncertainties, We See the Most Value In Banks and Credit Services
-
Consumer Cyclicals: Even With Anxiety Over Spending, We See Attractive Valuations