Shots:

• The P-III (NAPOLI 3) trial evaluates Onivyde (irinotecan liposome inj.) + 5 fluorouracil/leucovorin and oxaliplatin vs nab-paclitaxel + gemcitabine in 770 patients with mPDAC
• The trial met its 1EPs i.e., improvement in OS. The secondary efficacy outcome of PFS also showed significant improvement while the safety profile was consistent with that observed in the prior P-I/II study for mPDAC
• The company plans to file the sNDA of Onivyde + oxaliplatin & 5- fluorouracil/leucovorin with the US FDA for the same indication. Onivyde has been approved in major markets incl. the US, EU & Asia in combination with 5-FU and LV for metastatic pancreatic adenocarcinoma

Ref: Ipsen | Image: Ipsen