UPDATE 1-U.S. FDA okays Celgene's Abraxane for pancreatic cancer
Sept 6 (Reuters) - U.S. regulators on Friday approved use of Celgene Corp's Abraxane to treat patients with pancreatic cancer that has spread to other parts of the body, citing a trial that showed the drug significantly prolonged survival.
The medicine is already approved in the United States to treat lung cancer and breast cancer.
Celgene in January said Abraxane helped patients with advanced pancreatic cancer live an average of two months longer than those treated with chemotherapy, according to a late-stage study. Moreover, a significantly higher percentage of Abraxane users survived for up to two years.
Patients who received Abraxane in combination with the chemotherapy agent gemcitabine had a median overall survival of 8.5 months, compared with 6.7 months for patients who received standard therapy of gemcitabine alone. The result was deemed to be statistically significant.
Abraxane plus gemcitabine demonstrated a 59 percent increase in one-year survival, 35 percent vs 22 percent. The combination also doubled the percentage of patients who survived for two years from the start of treatment, with 9 percent still alive compared with 4 percent for gemcitabine alone.
Researchers said it was the first study in advanced pancreatic cancer to report two-year survivors.