Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene (Nasdaq: CELG), say that Swissmedic, the regulatory authority for Switzerland, has approved Abraxane (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer.

Abraxane has been approved in more than 30 countries for metastatic pancreatic cancer and over 40 countries for metastatic breast cancer. The drug’s global sales were $215 million for the second quarter of 2014, a 39% year-on-year increase.

The approval for Abraxane in pancreatic cancer is particularly meaningful, as there have been no new medications approved in nearly seven years and more than 30 clinical trials have failed to lead to regulatory approval in the European Union for advanced or metastatic pancreatic cancer. In Switzerland, pancreatic cancer has the fourth highest cancer mortality rate, affecting an estimated 1,000 patients in the next year. Median life expectancy after diagnosis with metastatic pancreatic cancer is only three–six months.