FDA Grants Fast Track Status to Tesaro’s Niraparib for Ovarian, Other Cancers

FDA Grants Fast Track Status to Tesaro’s Niraparib for Ovarian, Other Cancers
Tesaro has received fast track designation from the U.S. Food and Drug Administration (FDA) for the use of niraparib in patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. The FDA's fast track program will facilitate niraparib's development and expedite review to address highly unmet medical needs. As part of the fast track program, the FDA allows for the submission of completed portions of a new drug application (NDA), which proposes the FDA approve a new pharmaceutical for sale and marketing in the U.S. on an ongoing or rolling basis. Tesaro has already initiated an NDA rolling submission for niraparib and expects to complete the submission later this year. Tesaro also intends to submit a marketing authorization application for niraparib to the European Medicines Agency in the fourth quarter of this year. "The initiation of this rolling NDA submission is a significant milestone for Tesaro, and we are committed to working collaboratively with the FDA to advance the review of the niraparib application," Mary Lynne Hedley, PhD, Tesaro's president and chief operating officer, said in a press release. Niraparib is an oral PARP inhibitor that is being developed for tumors with mutations in proteins involved in DNA repair such as BRCA. By inhibiting PARP, which is also involved in the cell's DNA repair mechanisms, niraparib induces a high number of errors in the tumor cell's genetic material, ultimately resulting in cell death. Currently, Tesaro is evaluating niraparib in four ongoing clinical trials, including the do
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One comment

  1. Harsh says:

    Hi,
    Can anybody suggest if this drug will be useful in Platinum resistant Ovarian Cancer patients as well.
    Was that also the part of the study?
    Thanks,
    Harsh

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