September 10, 2013
ST LOUIS (MD Consult) - On September 6, 2013, the US Food and Drug Administration (FDA) approved Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for the treatment of patients with metastatic pancreatic cancer. The drug is intended for use with gemcitabine. Abraxane has been previously approved for the treatment of breast cancer and non-small cell lung cancer.
The safety and effectiveness of Abraxane for use in pancreatic cancer were established in a clinical trial with 861 participants who were randomly assigned to receive either Abraxane plus gemcitabine or gemcitabine alone. Participants treated with Abraxane plus gemcitabine survived, on average, 1.8 months longer than patients treated with gemcitabine alone. Additionally, participants who received Abraxane plus gemcitabine experienced progression-free survival that was, on average, 1.8 months later than the participants who only received gemcitabine.
Common adverse effects observed in Abraxane plus gemcitabine-treated participants included neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, rash, and dehydration. The most common serious adverse effects were pyrexia, dehydration, pneumonia, and vomiting.
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