British Biotech’s Breast Cancer Drug gets FDA Approval for Novartis

Novartis has received FDA approval for Kisqali, a first-line treatment for breast cancer originally developed by the British biotech Astex Pharmaceuticals.

The oncology company Astex Pharmaceuticals, located in Cambridge’s biotech hub, entered a drug discovery alliance with Novartis back in 2005. Now, the biotech will receive a milestone payment for the FDA approval of Kisqali (ribociclib) in the US. Novartis estimates peak sales of €2.35Bn ($2.5Bn) a year for the drug.

The drug is specifically prescribed for post-menopausal women that test positive for hormone receptor (HR+) and negative for human epidermal growth factor receptor-2 (HER2-), which is the most common type of metastatic breast cancer.


Kisqali, previously known as LEE011, inhibits two cell cycle proteins, CDK4 and CDK6. Their hyperactivity is linked to the growth of tumors. The approval of the drug as a first-line treatment in based on results from a Phase III trial in which the combination of Kisqali and letrozole reduced the risk of disease progression and death by 44% compared to letrozole alone. The EMA is currently reviewing this results and a decision is expected in the second half of this year.

Kisqali Novartis Astex Pharmaceuticals mechanism of action

The approval of Kisqali makes Novartis a direct competitor of Pfizer, whose drug Ibrance (palbociclib) was approved in the US 2015 as the first drug for ER+/HER2- breast cancer that targets CD4/CD6. Eli Lilly ‘s abemaciclib, another drug sharing the same mechanism of action, is currently in Phase III.

For Astex Pharmaceuticals, the success of its collaboration with Novartis is a reason to celebrate. This outcome reflects the great potential of its Pyramid drug discovery platform, which uses drug fragments for rapid screening of molecules with therapeutic potential. The British company, owned by the Japanese Otsuka Pharmaceuticals, is also collaborating with big European pharma, such as AstraZeneca, Janssen and GSK.

Images from PR Image Factory; Eli Lilly

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