Ipsen: obtains 'fast track' designation from FDA

(CercleFinance.com) - Ipsen announces that it has received FDA Fast Track designation for Liposomal irinotecan (ONIVYDE) as a first-line combination therapy for metastatic pancreatic cancer.


The FDA's Fast Track program is designed to facilitate the development and accelerate the review of drugs that target serious medical conditions and have the potential to address an unmet medical need.

Final analysis of the Phase 1/2 clinical study will be presented as a late-breaking virtual presentation at the ESMO World Congress on Gastrointestinal Cancer (WCGI) on 1 July 2020

"The final analysis... will include data on primary and secondary endpoints. Ipsen has also initiated patient enrollment in the international Phase 3 NAPOLI-3 clinical study investigating the safety and efficacy of NALIRIFOX versus gemcitabine + nab-paclitaxel in the first-line setting (NCT04083235)," Ipsen said.


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