Key Takeaways
- Novartis said its Kisqali breast cancer drug produced longer success for those with certain forms of the disease.
- The drug maker reported Kisqali along with endocrine therapy (ET) reduced the risk of recurrence in the test group by nearly 30% compared to ET alone.
- Novartis expects the FDA to decide on approval of the treatment this quarter.
American depositary receipts (ADRs) of Novartis (NVS) gained Monday as new research showed the company’s breast cancer treatment, Kisqali, produced longer success than originally thought.
The company reported an updated analysis of a Phase 3 clinical trial of Kisqali combined with endocrine therapy (ET) found “a deepening benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5%” for those with stage II or III HR+/HER2- early breast cancer compared to ET alone.
Trial investigator Dr. Peter Fasching noted that patients diagnosed with that form of breast cancer face “substantial risk of cancer coming back as metastatic disease,” and that clinicians have been looking for ways to address it. Dr. Fasching added that the results were important because the study included a broad range of those at risk of recurrence who need new treatment options to reduce that risk.
Novartis Expects FDA Decision This Quarter
Novartis explained that it submitted the results to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) last year, and expects FDA regulatory action on approval for the treatment this quarter.
Novartis ADRs, which were up about 1% to $116.61 soon after the opening bell Monday, hit an all-time high late last month, and although they’ve lost some ground, they’re still up 15% this year.
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