🇺🇸 Kisqali in United States

FDA authorised Kisqali on 13 March 2017

Marketing authorisations

FDA — authorised 13 March 2017

  • Application: NDA209092
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: KISQALI
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Kisqali, developed by Novartis, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. This approval was granted on February 11, 2025, under the standard expedited pathway. Kisqali is intended for patients who have received at least one prior endocrine therapy for advanced or metastatic breast cancer.

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FDA — authorised 11 February 2025

  • Application: NDA209935
  • Marketing authorisation holder: NOVARTIS
  • Indication: Labeling
  • Status: approved

The FDA granted marketing authorization to Novartis' Kisqali for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. This approval was based on a standard application pathway. Kisqali is a CDK4/6 inhibitor that works by blocking the growth of cancer cells.

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FDA

  • Application: ANDA215677
  • Marketing authorisation holder: ALEMBIC PHARMS LTD
  • Local brand name: RIBOCICLIB
  • Indication: TABLET — ORAL
  • Status: approved

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Kisqali in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Kisqali approved in United States?

Yes. FDA authorised it on 13 March 2017; FDA authorised it on 11 February 2025; FDA has authorised it.

Who is the marketing authorisation holder for Kisqali in United States?

NOVARTIS holds the US marketing authorisation.