Philogen and Sun Pharmaceutical (Sun Pharma) have announced the filing of a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for Nidlegy, an investigational neoadjuvant therapy, for locally advanced, fully resectable melanoma. Intended to be administered intralesionally for four weeks, Nidlegy aims to enhance the immune response against neoplastic lesions. The gold standard of business intelligence.
The submission is a significant milestone, marking the first MAA for Nidlegy in this treatment setting. The application is supported by data from the Phase III PIVOTAL study (PHL19IL2TNF-02/15) and a Phase II clinical trial (PHL19IL2TNF-02/12). The multicentre, global, comparator-controlled, randomised, parallel-group Phase III trial assessed the safety and efficacy of intratumoral doses of Nidlegy as a neoadjuvant treatment, followed by standard-of-care (SOC) treatment of surgery versus SOC alone.
It enrolled 256 subjects across 22 European clinical sites. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly 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 Nidlegy significantly reduced the relapse or death risk – a reduction of 41% versus control.
The median .
