FDA approves Onivyde (irinotecan liposome injection) + fluorouracil and leucovorin to treat metastatic pancreatic cancer- Merrimack Pharma

The FDA has approved Onivyde (irinotecan liposome injection) from Merrimack Pharma, in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The effectiveness of Onivyde was demonstrated in a three-arm, randomised, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy. The study was designed to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or irinotecan alone lived longer than those receiving fluorouracil/leucovorin. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin. In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumour growth compared to those who received fluorouracil/leucovorin. The average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months compared to 1.5 months for those receiving fluorouracil/leucovorin.

Comment: The EU rights are held by Baxalta which filed Onivyde with the EMA in May 2015.