FDA Grants Abraxane Priority Review for the Treatment of Pancreatic Cancer

nab-paclitaxel (Abraxane), as part of its supplemental new drug application for the first-line treatment of patients with metastatic pancreatic cancer when administered in combination with gemcitabine.

Abraxane is being considered for review based on the results of the phase III Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), which were presented at the 10th Annual Gastrointestinal Cancers Symposium in January 2013. In the trial, 861 patients with stage IV pancreatic cancer who received no prior treatments for metastatic disease were randomized to receive eithernab-paclitaxel at 125 mg/m²followed by gemcitabine 1000 mg/m²(n = 431) or gemcitabine alone (n = 430). Patients received treatment until their disease progressed.

Patients who received thenab-paclitaxel combination had a median overall survival of 8.5 months compared with 6.7 months in patients who received gemcitabine alone (hazard ratio [HR] = 0.72;P=.000015). The one-year survival rate was 35% in thenab-paclitaxel arm compared with 22% in the gemcitabine arm (P= .0002). The median progression-free survival was also higher in thenab-paclitaxel arm at 5.5 months compared with 3.7 months in the gemcitabine alone arm (HR=0.69;P= .000024).

Nab-paclitaxel showed overall response rate benefit: 23% compared with 7% in the gemcitabine alone arm. Time to treatment failure was longer in the combination arm at 5.1 months compared with 3.6 months in the control arm (HR = 0.70;P= .0001).

In 2012,nab-paclitaxel, in combination with carboplatin, received FDA approval for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer who cannot receive surgery or radiation therapy.

The FDA has not approved any drugs for pancreatic cancer since 2005. In 2005, erlotinib was approved for the treatment of locally advanced, unresectable or metastatic disease.

The FDA can assign a breakthrough therapy designation to drugs that treat a life-threatening condition and demonstrate a substantial improvement over existing therapies. This type of designation promotes an expedited review process: It allows for more meetings between the FDA and the manufacturer during development, requires fewer patients for clinical trials, and reduces the amount of time required for these trials.

According to Celgene International Sàrl, a subsidiary of Celgene Corporation, a phase III, international, multicenter, randomized controlled trial evaluating the activity ofnab-paclitaxel plus gemcitabine as an adjuvant treatment for pancreatic cancer is currently under development.

An action date fornab-paclitaxel in pancreatic cancer, in accordance with the Prescription Drug User Fee Act (PDUFA), is set for September 21, 2013.

Von Hoff DD, Ervin TJ, Arena FP, et al. Randomized phase III study of weeklynab