Home Business FDA panel to review GSK Zejula’s overall survival data in recurrent ovarian cancer

FDA panel to review GSK Zejula’s overall survival data in recurrent ovarian cancer

by WDC News 6 Staff


William Barton

GSK (NYSE:GSK) mentioned on Sept. 22 {that a} panel of the U.S. Meals and Drug Administration (FDA) is scheduled to carry a gathering on Nov. 22 to debate general survival (OS) knowledge from a part 3 trial of Zejula (niraparib) for recurrent ovarian most cancers.

Development-free survival (PFS – size of time throughout/after remedy a affected person lives with the illness with out it getting worse) knowledge from the part 3 trial known as NOVA (ENGOT-OV16) served as the principle foundation of Zejula’s approval as a upkeep remedy for girls with recurrent epithelial ovarian, fallopian tube, or major peritoneal most cancers who’re in full or partial response to platinum-based chemotherapy, the corporate mentioned in a Sept. 22 press launch.

GSK famous that OS was a secondary purpose and that up to date ultimate OS knowledge was lately shared with the FDA.

The British pharma big added that the assembly of the Oncologic Medication Advisory Committee (ODAC) will not be associated to Zejula’s use as a upkeep remedy for sure grownup sufferers with superior ovarian most cancers.

The FDA had authorized the expanded use of Zejula in April 2020 as upkeep therapy for sure girls with superior ovarian most cancers.

GSK -1.03% to $29.70 premarket Sept. 23



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