NICE rebuffs Celgene's Abraxane in pancreatic cancer over limited benefits, cost

The National Institute for Health and Care Excellence issued draft guidance recommending against NHS funding of Celgene's Abraxane (nab-paclitaxel), in combination with Eli Lilly's Gemzar (gemcitabine), for previously untreated metastatic pancreatic cancer as the drug "has limited benefits compared to current treatments and it is more costly." Abraxane received European approval in this indication in January.

According to NICE, Celgene submitted study results showing that the use of Abraxane plus Gemzar led to a significant 2.1-month improvement in overall survival (OS) and a 1.8-month improvement in progression-free survival (PFS) versus Gemzar alone. However, the company also provided data indicating that the combination of Abraxane and Gemzar was associated with a shorter OS and PFS compared to the FOLFIRINOX chemotherapy regimen, and with a similar OS and PFS versus Gemzar plus Roche's Xeloda (capecitabine).

In addition, NICE said that the combination of Abraxane and Gemzar resulted in more serious side effects than Eli Lilly's drug alone, while the combination may also have more side effects than Gemzar and Xeloda. The agency noted that side effects linked to the use of Abraxane with Gemzar include an increased risk of infection, bleeding problems, tiredness and breathlessness, numbness or tingling in fingers and toes, gastrointestinal problems, aching joints and muscles, tiredness, nausea and hair loss.

Commenting on the recommendation, NICE chief executive Andrew Dillon said "we are disappointed that, when considering the impact of side effects as well as how effective the treatment is the evidence fails to show that it works any better for patients than other treatments already provided by the NHS. It is also more expensive." According to Celgene, the average cost of a 28-day course of Abraxane is 1481 pounds ($2388).

Abraxane was approved in Europe in 2008 for the treatment of metastatic breast cancer.

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