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GSK PLC on Thursday said its cancer drug Zejula will be reviewed by the US Food & Drug Administration for overall survival data for patients with ovarian cancer.
The FDA and GSK will hold an Oncologic Drugs Advisory Committee meeting on November 22 to discuss overall survival data.
Zejula, or niraparib, is a cancer drug in the form of an oral pill. It used to treat recurrent ovarian, advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers in patients who are in a complete or partial response to first-line platinum-based chemotherapy.
The discussion with the FDA will only be about Zejula's recurrent ovarian cancer survival data, explained Hesham Abdullah, senior vice president and global head of GSK's Oncology Development unit.
Earlier in September, GSK said Zejula showed a long-term survival benefit in a phase III ovarian cancer study.
Back then it said homologous recombination deficient patients, who were treated with Zejula, were predicted to be more than twice as likely free of progression or death at four years compared to a placebo.
GSK shares closed 0.4% lower at 1,299.40 each in London on Thursday.
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