FDA approves Abraxane for first-line treatment of the most common type of lung cancer
The USFDA has approved Abraxane for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with carboplatin. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. It is formulated with albumin, a human protein, and is free of solvents. The Abraxane sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study.
This approval marks the second indication for Abraxane in the United States. It was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy. Apart from the US, Abraxane is also available in Europe, Canada, Russia, Australia, New Zealand, India, South Korea, Bhutan, Nepal, United Arab Emirates and China for the treatment of metastatic breast cancer.
"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 Abraxane 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."
Abraxane is currently in various stages of investigation for the treatment of cancers such as pancreatic, metastatic melanoma, bladder, ovarian, and expanded applications for breast cancer.
In India, Panacea Biotec had launched PacliALL, an indigenously developed formulation of the Paclitaxel, the active ingredient of Abraxane in February 2011.