FDA Accepted GSK’s Application for ZEJULA with Priority Review

| By | FDA, GlaxoSmithKline, New Drug Application

GlaxoSmithKline plc announced that TESARO, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZEJULA (niraparib). The application was granted priority review and has an action date of 24 October 2019.

The sNDA supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either:

  • BRCA mutation or
  • Homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy.

Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of TESARO, said,

“The results of the QUADRA study demonstrate that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA.”

Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said:

“We know ZEJULA plays an important role in helping women with ovarian cancer whose disease has progressed despite initial therapy. Our hope is that over time, our ongoing clinical trials will demonstrate that this medicine can benefit even more patients.”

The niraparib sNDA is supported by data from the QUADRA trial. Data from the QUADRA trial were recently published in Lancet Oncology.

SOURCE: gsk.com
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