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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

Philogen CEO and chief scientific officer Dario Neri stated: “The validation of the dossier by the EMA represents the first important milestone for the MAA review process.”

“Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”