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(Alliance News) - GlaxoSmithKline PLC on Thursday said its drug Zejula has been granted US approval as a first-line maintenance treatment for advanced ovarian cancer.
The US Food & Drug Administration approved Zejula, the brand name for niraparib, to be given once-daily to patients with advanced ovarian, primary peritoneal, or fallopian tube cancer - regardless of biomarker status - which has completely or partially responded to platinum chemotherapy.
Zejula, the FTSE 100-listed drug maker noted, "is the only oral monotherapy available as first-line maintenance treatment for women regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer". BRCA mutations are associated with cancers such as ovarian cancer.
Each patient's starting dose for Zejula will be individualised, as doing so produced "lower rates of haematological adverse events" when studied. The dose will be calculated using using the patient's baseline weight, their platelet count, or both.
Glaxo's supplemental new drug application for Zejula has been approved under the FDA's "real-time oncology review" pilot programme. This new indication was supported by data from Glaxo's phase 3 Prima study, which found that the drug "significantly improved" progression-free survival.
Hal Barron, chief scientific officer at Glaxo and president of Research & Development, said: "Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress."
Shares in Glaxo were up 0.4% at 1,682.80 pence in London in Thursday morning trade.
By Anna Farley; annafarley@alliancenews.com
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