On June 24, 2025 Philogen S.p.A (BIT: PHIL) ("Philogen") reported the decision to voluntarily withdraw 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 (Press release, Philogen, JUN 24, 2025, View Source [SID1234654089]).
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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). Until now, Nidlegy has been given to more than 450 patients with different types of skin cancer.
The company continues to closely interact with the EMA and with the medical community, with the goal of making Nidlegy available to both melanoma and non-melanoma skin cancer patients as soon as possible.
Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy and resubmit an updated application, in view of the potential of the product in melanoma and beyond. We are working closely together with EMA to address their requests in preparation of the forthcoming resubmission of the MAA."