The US Food and Drug Administration (FDA) today approved a sixth indication for bevacizumab (Avastin, Genentech/Roche) — treating patients with persistent, recurrent, or late-stage cervical cancer.
The new indication calls for administering bevacizumab withpaclitaxel along with either cisplatin or topotecan.
In a news release, the agency said that bevacizumab is the first drug approved for late-stage cervical cancer since the debut of topotecan in combination with cisplatin in 2006.
Bevacizumab already had been approved to treat metastaticrenal cell carcinoma, glioblastoma, non-squamous non-small cell lung cancer, and metastatic colorectal cancer under 2 separate indications.
The FDA determined that bevacizumab was safe and effective in treating cervical cancer based on a clinical study involving 452 participants with a persistent, recurrent, or late-stage form of the disease. Overall survival increased by 16.8 months for participants who received the drug with paclitaxel and cisplatin, or paclitaxel and topotecan. Survival for those who received the different chemotherapy combinations without bevacizumab increased by only 12.9 months.
Fatigue, decreased appetite, hypertension, hyperglycemia, and urinary tract infections were among the most common adverse events observed in the study. Some patients receiving bevacizumab also experienced perforations of the gastrointestinal tract and enterovaginal fistulas, according to the FDA.
The label for bevacizumab features boxed warnings about gastrointestinal perforations, complications for surgery and wound healing, and hemorrhage, which were issued before the FDA approved the drug for cervical cancer.
More information about today's decision is available at the FDA Web site.
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