Merrimack Pharma's pancreatic cancer drug wins FDA approval

Last Updated: 2015-10-22

By Samantha Kareen Nair

(Reuters) - The U.S. Food and Drug Administration on Thursday approved Merrimack Pharmaceutical Inc's pancreatic cancer drug Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The drug is not approved for use as a single agent for the treatment, the FDA said.

The effectiveness of Onivyde was demonstrated in a randomized study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown following gemcitabine or a gemcitabine-based therapy.

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, the FDA said.

In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumor 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.

The drug carries a black box warning about possible risks of diarrhea and neutropenia.