Wednesday, September 5, 2012

Dainippon Sumitomo Pharma submits an application for anticancer antibiotic amrubicin HCI (Brand name in Japan: CALSED®) in China

Dainippon Sumitomo Pharma Co., Ltd. has submitted an imported drug registration application in China for anticancer antibiotic amrubicin HCI ( Brand name in Japan: CALSED®) to the State Food and Drug Administration, P.R. China (SFDA) for the treatment of small cell lung cancer.The application is  based on
data from Phase 3 studies in China on new (untreated) patients of extensive disease small cell lung
cancer. In the Phase 3 study,  a combination of amrubicin HCl and cisplatin HCl was compared to a combination of cisplatin and etoposide, the standard therapy for small cell lung cancer. As a result,
non-inferiority of the amrubichin-cicplatin combination vs the cisplatin-etoposide combination was
demonstrated at the primary endpoint of “overall survival”.

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