Abraxis BioScience has announced that the Korean FDA has granted marketing approval for Abraxane for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease.
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The Phase III clinical trial results on which this approval was based demonstrated that Abraxane doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol in the approved indication. Abraxane is now approved for marketing in 34 countries.
Abraxis granted an exclusive license to Green Cross for the commercialization of Abraxane in Korea. Green Cross currently expects to launch Abraxane in Korea in the first quarter of 2009 following pricing approval. Green Cross plans to establish a dedicated sales force for Abraxane and implement various marketing campaigns to support a successful launch.
Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, said: “The approval for Abraxane in Korea provides an effective new treatment option to physicians and patients in Korea in the fight against metastatic breast cancer. We look forward to expanding the global market presence of Abraxane.”
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