Dainippon Sumitomo files for approval of Calsed in China

Japanese drug major Dainippon Sumitomo Pharma (TYO: 4506) has submitted an imported drug registration application in China for anticancer antibiotic amrubicin HCI (brand name Calsed in Japan) to China’s  State Food and Drug Administration, for the treatment of small cell lung cancer.

In Phase III studies in China on new (untreated) patients of extensive disease small cell lung cancer, 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 versus the cisplatin-etoposide combination was demonstrated at the primary endpoint of “overall survival.” Receiving these results, Dainippon Sumitomo submitted an imported drug registration application to the SFDA for amrubicin HCl as a first-line treatment for small cell lung cancer.

By providing a new treatment for small cell lung cancer in China, DSP hopes to contribute to the treatment of Chinese patients with lung cancer.