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news.Biocon and Abraxis BioScience have launched Abraxane in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
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Abraxane is now available in India as a single-use 100mg vial (as a lyophilized powder, to be reconstituted for intravenous administration).
In October 2007, Abraxane was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the US. The Phase III clinical trial in the US demonstrated that Abraxane nearly doubled the response rate, significantly prolonged time to progression, and significantly improved overall survival in the second-line setting versus solvent-based Taxol in the approved indication.
Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said: “Abraxane is a significant advance in taxane therapy for the treatment of breast cancer. This unique product eliminates the need for chemical solvents and allows for higher doses of paclitaxel without compromising safety and tolerability.”