Novartis AG is poised to significantly expand the market and sales for Kisqali (ribociclib) with the CDK4/6 inhibitor’s new US Food and Drug Administration approval for treatment of patients with early breast cancer.
Kisqali Label Expansion Will Double Market Size Opportunity
The US FDA approved the drug with a broad label for patients with HR+/HER2- early breast cancer at high risk of recurrence, a potentially multibillion-dollar opportunity.

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.
After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.
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Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
The four-year-old firm said it plans to advance programs toward the clinic from the funding round, which comes just over a year after signing two major pharma partnerships.
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.