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EU Regulator Grants Label Expansion for GlaxoSmithKline's Ovarian Cancer Therapy

On Thursday, GlaxoSmithKline (NYSE: GSK) announced that the European Commission had approved Zejula as a first-in-line therapy for adult patients who have ovarian, fallopian tube, or primary peritoneal cancer, following chemotherapy. The FDA approved the drug for the same indications back in April.

"Over 65,000 women in Europe are diagnosed with ovarian cancer each year," noted Dr. Hal Barron, the chief science officer at GlaxoSmithKline. "This approval of Zejula means that many more women will have the option to receive this innovative medicine earlier, potentially expanding the time they may spend without their devastating cancer progressing."

Image source: Getty Images

According to the Centers for Disease Control and Prevention, ovarian cancer is the seventh-deadliest cancer in the United States. It often goes undetected until it spreads into the pelvis and abdomen. The American Cancer Society estimates that 21,000 U.S. women will be diagnosed with ovarian cancer this year, and almost 14,000 will die from the disease.

The drug's expanded approval was based on the pivotal PRIMA study, which tested Zejula in the HRd (homologous recombination deficient) population, and then in the overall population of women with the disease. In the HRd population, the drug produced a 57% reduction in disease progression or death versus placebo. In the overall population, there was a 38% reduction in the risk of disease progression or death.

In Wednesday's conference call, GlaxoSmithKline management reported revenue of 92 million pounds from Zejula in the third quarter. This expanded approval in Europe should increase its sales significantly. The stock was up slightly in late-afternoon trading Thursday.

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