Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized ipilimumab in combination with nivolumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.

This is written in the approval document as:

YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

Citation

Bristol-Myers Squibb Pharma EEIG. Yervoy (ipilimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf. Revised March 2025. Accessed September 5, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Paclitaxel