Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Dive Brief:

• Novartis will pause enrollment in certain clinical trials of its breast cancer drug Kisqali in order to meet regulators’ concerns around impurities related to nitrosamines, the company said Tuesday. The stoppage will allow Novartis to adjust its manufacturing in response.
• The move won’t affect commercial supply of Kisqali, which is approved in patients with advanced and metastatic disease, Novartis said. Only enrollment in studies testing the drug in early breast cancer will be suspended, and the company does not expect a delay in the regulatory review of Kisqali for this use.
• The Food and Drug Administration has sought to reduce patient exposure to nitrosamine impurities over worries they might cause cancer. In August 2023, the FDA published guidance on their reduction in drug products, with which Novartis plans to comply by the end of June.

Dive Insight:

The pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but not with a therapy like Herceptin that targets a protein called HER2. This type of tumor, referred in shorthand as HR+ and HER2-, accounts for roughly 70% of all breast cancer cases in the U.S.

Kisqali specifically targets a protein called CDK4/6, as does Eli Lilly’s Verzenio and Pfizer’s Ibrance. Ahead of the other two, Verzenio won approval in the post-surgical, “adjuvant” treatment setting to prevent recurrence of disease. The approval helped spur a 56% jump in sales to $3.9 billion last year. By comparison, Kisqali had sales of $2.1 billion and Ibrance $4.8 billion, the latter number falling by 6% because of competitive pressure and price reductions.

Ibrance didn’t help patients in the adjuvant setting, putting it at a competitive disadvantage once Verzenio did. Novartis likewise had good fortune when its Phase 3 trial read out positive data for a wider group of patients than were enrolled in Lilly’s trial of Verzenio.

Novartis asked the FDA to approve Kisqali in this setting in the fourth quarter of 2023, putting it on track for a FDA decision sometime in the second half of 2024, if, as Novartis stated, the manufacturing change won’t affect regulatory review.

Nonetheless, the manufacturing scrutiny will be a “marginal” positive for Eli Lilly, provided Verzenio doesn’t have the same impurities, Evercore ISI analyst Umer Raffat wrote in a note to clients.

Raffat notes there is the possibility Verzenio could have the same issue, but added that, if it had been seen, “there should have been some regulatory update on it.”

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