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Area of Science:

  • Pharmacology
  • Oncology supportive care

Background:

  • Chemotherapy-induced nausea and vomiting (CINV) remains a significant challenge for patients undergoing cancer treatment.
  • Neurokinin-1 (NK-1) receptor antagonists and 5-hydroxytryptamine-3 (5-HT3) receptor antagonists are key classes for managing CINV.

Purpose of the Study:

  • To summarize the development milestones of fosrolapitant/palonosetron (Ritanine®).
  • To highlight the drug's first approval for preventing CINV in China.

Main Methods:

  • Review of preclinical and clinical development data for fosrolapitant/palonosetron.
  • Analysis of regulatory submission and approval process in China.

Main Results:

  • Fosrolapitant, a novel NK-1 receptor antagonist prodrug, and palonosetron, a second-generation 5-HT3 receptor antagonist, form a fixed-dose combination.
  • On May 29, 2025, fosrolapitant/palonosetron received its first marketing approval in China.
  • The approval is for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy in adults.

Conclusions:

  • Fosrolapitant/palonosetron represents a significant advancement in CINV management.
  • The approval in China marks a crucial milestone for this novel fixed-dose combination therapy.