Abraxane gets FDA approval for new indication

Singapore: The US Food and Drug Administration (FDA) has approved Celgene's Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

"Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States," said Dr Mark A Socinski, director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of the phase II and phase III lung cancer trials. "The FDA approval of Abraxane is exciting for healthcare professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years."

The Abraxane sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study where patients with advanced non-small cell lung cancer received either Abraxane (100mg/m2) weekly plus carboplatin every three weeks or paclitaxel (200mg/m2) every three weeks plus carboplatin. The study met its primary end-point demonstrating a statistically significantly higher overall response rate for patients in the Abraxane arm compared to those in the paclitaxel arm.

This approval marks the second indication for Abraxane in the US. It was first approved in the US in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy. Additional regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.