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)

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