EMA validates Philogen and Sun Pharma’s MAA for melanoma
05 Jul 2024
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Source: Pharmaceutical Technology
A total of 256 patients were enrolled across 22 clinical centres in Germany, Italy, France and Poland. Credit: Gorodenkoff / Shutterstock.
The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma.
Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma.
The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial.
The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection.
A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland.
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Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS).
Nidlegy’s safety profile was characterised by mostly low-grade, local adverse events.
No grade 3 or grade 4 immune-related adverse events or drug-related deaths were recorded.
Nidlegy is a biopharmaceutical product of Philogen, designed to treat skin cancer through intralesional administration of two active ingredients, L19IL2 and L19TNF.
These ingredients are pro-inflammatory cytokines with potent anti-tumour activity.
Nidlegy is also being investigated in additional Phase III trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers.
“Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”
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