Sun Pharma has announced that its partner, Italian-Swiss biotechnology company Philogen, has resubmitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of Nidlegy, an investigational product for the neoadjuvant treatment of adults with locally advanced, fully resectable melanoma.
Under a licensing agreement signed with Philogen in May 2023, Sun Pharma holds exclusive commercialization rights for Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers.
The updated application is supported by data from the randomized Phase III PIVOTAL trial, which demonstrated that Nidlegy reduced the risk of disease relapse or death compared with the control group. The resubmission also includes additional Chemistry, Manufacturing and Controls (CMC) information to address the outstanding questions raised during the previous EMA review.
Alongside the Phase III findings, the application contains efficacy and safety data from a Phase II study, safety data from the ongoing Phase III NeoDREAM trial, and results from a Phase II study in non-melanoma skin cancer.
According to Philogen, compared with the original MAA submitted in June 2024, the revised dossier incorporates a longer median patient follow-up of 33 months, up from 21 months, along with additional post hoc analyses focusing on event-free survival. While the data supporting the 2024 submission were published in Annals of Oncology, the updated findings have been accepted for publication in the Journal of Clinical Oncology and are expected to appear online in the coming weeks.
Commenting on the resubmission, Prof. Dr. Dario Neri, CEO and Chief Scientific Officer of Philogen, said, “Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. In parallel, we have continued to expand the global Phase III NeoDREAM melanoma study and have launched additional registrational studies in non-melanoma skin cancers.”
Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of high-risk basal cell carcinoma and other non-melanoma skin cancers.
Under the licensing agreement, Philogen is responsible for completing pivotal clinical trials for Nidlegy in Europe, securing regulatory approvals, and manufacturing commercial supplies.
Sun Pharma will lead commercialization activities across Europe, Australia, and New Zealand, with both companies sharing post-commercialization economics on an approximately 50:50 basis. Philogen retains the intellectual property rights for Nidlegy in other territories and for indications beyond skin cancers.
