BioCentury
ARTICLE | Clinical News

Abraxane nab-paclitaxel regulatory update

September 15, 2014 7:00 AM UTC

The U.K.'s NICE issued draft guidance recommending against the use of Celgene's Abraxane nab-paclitaxel for first-line treatment of metastatic pancreatic cancer in combination with gemcitabine -- an indication the European Commission approved in January. The committee said the albumin stabilized nanoparticle formulation of paclitaxel has limited benefit compared to standard of care (SOC) for pancreatic cancer and is more costly.

According to NICE, Abraxane plus gemcitabine was associated with longer overall survival (OS) and progression-free survival (PFS) compared with gemcitabine alone in metastatic pancreatic cancer. However, the committee said the OS and PFS were shorter compared with FOLFIRINOX, a chemotherapy regimen comprising fluorouracil, leucovorin, irinotecan and oxaliplatin that NICE said was the SOC for pancreatic cancer, or gemcitabine plus capecitabine, which is also used in clinical practice. NICE also noted that Abraxane plus gemcitabine led to more serious side effects than gemcitabine alone, though the committee said FOLFIRINOX was also associated with "considerable toxicity." ...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article