Philogen S.p.A., the European partner of Sun Pharmaceutical Industries, has submitted an updated Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for Nidlegy, an investigational immunotherapy for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.

The revised application builds on the original MAA submitted in June 2024 and incorporates updated clinical evidence from the randomized Phase 3 pivotal study PH L19IL2TNF-02/15. The new submission reflects an extended median patient follow-up of 33 months, compared with 21 months in the earlier filing, along with additional post hoc analyses focused on Event-Free Survival (EFS).

According to Philogen, the updated data further reinforce Nidlegy's clinical benefit. In the pivotal study, the investigational therapy significantly reduced the risk of disease relapse or death compared with the control arm while demonstrating a favourable safety profile, with most treatment-related adverse events being low-grade and localised.

The revised application also includes expanded Chemistry, Manufacturing and Controls (CMC) information intended to address questions raised during the previous EMA review process.

Clinical findings supporting the original 2024 submission were published in the Annals of Oncology in 2025. Meanwhile, the updated clinical results underpinning the resubmitted application have been accepted for publication in the Journal of Clinical Oncology and are expected to be published online in the coming weeks.

Commenting on the development, Professor Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, said the company remains committed to advancing Nidlegy for both melanoma and non-melanoma skin cancers. He noted that since the previous review, Philogen has worked extensively to address regulatory questions while simultaneously expanding the global Phase 3 NeoDREAM melanoma study and initiating additional registrational studies in non-melanoma skin cancers.

Neri added, "We are encouraged by the clinical data generated to date and will continue working closely with our partners and regulatory authorities to bring this innovative treatment to patients with significant unmet medical needs," 

Nidlegy is partnered with Sun Pharmaceutical Industries for the treatment of skin cancers across Europe, Australia and New Zealand, where Sun Pharma will support the product's commercialization if regulatory approval is granted.

The updated EMA submission represents an important regulatory milestone for both companies as they seek to expand treatment options for patients with resectable melanoma through innovative neoadjuvant immunotherapy.