Sun Pharma Partner Philogen Resubmits EMA Application for Melanoma Therapy Nidlegy
Mumbai: Sun Pharmaceutical Industries Limited has informed the stock exchanges that its partner, Philogen S.p.A., has resubmitted the Marketing Authorization Application (MAA) for Nidlegy (Daromun) to the European Medicines Agency (EMA). The application seeks approval of the investigational therapy as a neoadjuvant treatment for adult patients with locally advanced, fully resectable melanoma.
According to the company, the resubmission follows the timelines previously communicated by Philogen and incorporates updated clinical evidence generated from the randomized Phase III PIVOTAL study. The revised dossier includes a longer median patient follow-up of 33 months, compared to 21 months in the earlier submission made in June 2024, along with additional post-hoc analyses focusing on event-free survival.
The updated application also contains additional Chemistry, Manufacturing and Controls (CMC) information intended to address questions raised during the previous regulatory review. Supporting evidence further includes efficacy and safety data from a Phase II melanoma study, safety data from the ongoing Phase III NeoDREAM study, and findings from a Phase II study evaluating the therapy in non-melanoma skin cancers.
In the PIVOTAL Phase III trial, Nidlegy demonstrated a reduction in the risk of relapse or death compared with the control arm, while its safety profile was mainly characterized by low-grade local adverse events, according to Philogen.
Commenting on the development, Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, said the company remains committed to advancing Nidlegy for melanoma and non-melanoma skin cancers.
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“Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. We are encouraged by the data generated to date and will continue working with our partners and regulators with the aim of bringing this innovative treatment to patients in need,” he said.
Philogen noted that Sun Pharma is its commercialization partner for Nidlegy in Europe, Australia, and New Zealand for the treatment of skin cancers.
Nidlegy is a proprietary biopharmaceutical product comprising two active components, L19IL2 and L19TNF, designed for intralesional administration. The investigational therapy is currently being evaluated in two Phase III clinical trials for locally advanced melanoma and Phase II studies in high-risk basal cell carcinoma and other non-melanoma skin cancers.
Currently, there is no approved neoadjuvant drug for the treatment of locally advanced, fully resectable melanoma, making the regulatory review of Nidlegy a significant development in this therapeutic area.
