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FDA Approves Abraxane (Paclitaxel) for Late-Stage Pancreatic Cancer

Drug is administered with gemcitabine (September 6)

The FDA has expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound, Celgene) to treat patients with late-stage (metastatic) pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute. Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.

Abraxane is a chemotherapy drug that can slow the growth of certain tumors. It is intended to be used with gemcitabine (Gemzar, Eli Lilly), another chemotherapy drug, in patients with metastatic pancreatic cancer.

The safety and effectiveness of Abraxane for the treatment of pancreatic cancer were established in a clinical study of 861 participants who were randomly assigned to receive Abraxane plus gemcitabine or gemcitabine alone. Participants treated with Abraxane plus gemcitabine lived, on average, 1.8 months longer than those treated with gemcitabine alone. In addition, participants who received Abraxane plus gemcitabine experienced a delay in tumor growth (progression-free survival) that was, on average, 1.8 months later than tumor growth in participants who received only gemcitabine.

Common side effects observed in participants treated with Abraxane plus gemcitabine included neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, vomiting, alopecia, peripheral edema, diarrhea, fever, rash, and dehydration.

Abraxane was previously approved to treat breast cancer (2005) and non–small-cell lung cancer (2012).

Source: FDA; September 6, 2013.

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