A new therapy for advanced pancreatic cancer has been cleared in the US, albeit with a blackbox safety warning.

The US Food and Drug Administration has approved Merrimack’s Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients who have previously received gemcitabine-based chemotherapy.

Pancreatic cancer is notoriously difficult to diagnose early and treatment options are limited, especially once it has spread to other parts of the body and surgery to remove the tumour is not possible, creating a high level of unmet need.

In clinical trials, patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months compared to 4.2 months for those treated given fluorouracil/leucovorin. However, there was no survival improvement for patients who took only Onivyde versus those who received fluorouracil/leucovorin.

The results also showed that patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumour growth compared to those taking fluorouracil/leucovorin, at 3.1 months compared to 1.5 months, respectively. 

“With a long history of failed clinical studies in the post-gemcitabine setting, this approval is a significant achievement in the oncology community,” noted Andrea Wang-Gillam, clinical director of GI Oncology Program, Washington University School of Medicine. “It brings a new therapy to the many patients who are facing this aggressive disease and are in need of treatment options.”

On the down side, the drug does come with a boxed warning alerting healthcare professionals about the risks of severe neutropenia (abnormally low levels of white blood cells) and diarrhoea.

There are around 49,000 patients diagnosed with pancreatic cancer in the US each year.