Sun Pharma European partner Philogen pulls EMA application for skin cancer drug Nidlegy

Siena: Sun Pharma European partner Philogen S.p.A has voluntarily withdrawn the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy, a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma.

The Marketing Authorization Application (MAA) for Nidlegy submitted in June 2024 was supported by data from PIVOTAL (NCT02938299), a randomized Phase 3 study in 256 patients with locally advanced fully resectable melanoma, in which Nidlegy reduced the risk of relapse or death by 41% compared to the control arm (Hauschild et al. Journal of Clinical Oncology 2024, 43; Kähler et al Annals of Oncology, 2025, manuscript accepted). The safety profile of Nidlegy was characterized mostly by low-grade, local adverse events.

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls (CMC) and additional clinical data to better characterize the benefit:risk profile in patients with locally advanced resectable melanoma. Provision of the CMC and clinical data were unlikely to be completed within the current allowed timeframe. Philogen remains confident in the favorable benefit-risk profile of Nidlegy, underscored by its clinically meaningful efficacy and tolerable safety profile in both melanoma (Hauschild et al. Journal of Clinical Oncology 2024, 43, Kähler et al. Annals of Oncology, 2025, manuscript accepted) and in non-melanoma skin cancers (Flatz et al. JEADV 2025, 39, e147).