Philogen and Sun Pharma’s Nidlegy™ Advances in European Cancer Treatment

On July 4, 2024, Philogen S.p.A. ( and Sun Pharmaceutical Industries Limited announced via a stock exchange filing that the European Medicines Agency (EMA) had accepted their application to approve Nidlegy™. The application was submitted on June 3, and it has now entered the validation phase by the EMA.

“The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, Chief Executive Officer and Chief Scientific Officer at Philogen.

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

Nidlegy™, in partnership with Sun Pharma, aims to treat skin cancers in Europe, New Zealand, and Australia. Together, they announced the following milestones:

• On October 23, 2023, the Phase III PIVOTAL trial successfully met its primary objective.
• The primary results of the PIVOTAL trial were presented at ASCO on May 31, 2024.
• The Marketing Authorisation Application (MAA) for Nidlegy™ was submitted to the EMA on June 4, 2024. The Phase III trial data for Nidlegy™ will be announced in a peer-reviewed scientific journal in 2024.

About Nidlegy™ (Daromun)

Nidlegy™, also known as Daromun, is a biopharmaceutical developed by Philogen for treating skin cancer. It combines two active components, L19IL2 and L19TNF, which are produced separately and mixed before being injected into tumours.

Nidlegy™ is currently undergoing Phase III trials for advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other types of non-melanoma skin cancers.

About The Pivotal Phase III Study

The PIVOTAL Phase III study is an international clinical trial that gauges the effectiveness and safety of Nidlegy™ as a neoadjuvant treatment for melanoma. It compares intratumoral injections of Nidlegy™ followed by standard surgery with surgery alone as the standard treatment. The trial involved 256 patients across 22 European clinical centres (Germany, Italy, France, and Poland).

About Locally Advanced Fully Resectable Melanoma

Locally advanced, fully resectable melanoma is a type of skin cancer where abnormal melanocyte growth spreads to nearby lymph nodes or surrounding tissues. Current treatment involves surgery followed by approved drugs. Nidlegy™ aims to be the first approved drug for this condition in the neoadjuvant setting, administered directly into tumours before surgery.

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