Abstract
The U.S. Food and Drug Administration, in September 2013, approved the use of Abraxane in combination with gemcitabine to treat patients with late-stage pancreatic cancer.
The U.S. Food and Drug Administration (FDA), on September 6, approved the use of nab-paclitaxel (Abraxane; Celgene) in combination with gemcitabine (Gemzar; Eli Lilly) to treat patients with late-stage pancreatic cancer.
Nab-paclitaxel had previously been approved by the FDA for the treatment of metastatic breast cancer and, in combination with carboplatin, non–small cell lung cancer. The drug is an albumin-bound form of paclitaxel.
The latest approval was based on data from an international, multisite phase III clinical trial, announced in January, that compared 431 patients with metastatic pancreatic cancer who took nab-paclitaxel and gemcitabine with 430 patients who took gemcitabine alone. Patients treated with the nab-paclitaxel–gemcitabine combination lived an average of 1.8 months longer than those treated with gemcitabine alone. In addition, they experienced progression-free survival that was 1.8 months longer than the patients who received only gemcitabine.
Common side effects of the nab-paclitaxel–gemcitabine combination during the trial included neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, hair loss, peripheral edema, diarrhea, fever, vomiting, rash, and dehydration. Some physicians believe the combination may have fewer and less-severe side effects than FOLFIRINOX, a regimen of four intravenous chemotherapies often used as a first-line treatment. A side-by-side comparison of these two treatments has not been done.
Patients with pancreatic cancer face a grim prognosis: The 1- and 5-year survival rates are just 26% and 6%, respectively, according to the American Cancer Society. The mortality rate is so high because patients are often diagnosed after the disease has spread and cannot be surgically removed, says Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
“In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient's life,” adds Pazdur. The targeted therapy erlotinib (Tarceva; Genentech and Astellas), combined with gemcitabine, is also approved for advanced pancreatic cancer.
