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Thread: Zejula, also called niraparib approved by FDA

  1. #1

    Zejula, also called niraparib approved by FDA

    Zejula, also called niraparib approved by FDA.


    Tesaro Inc. TSRO, +6.55% shares rose 5.9% in after hours trade Monday after the company said its ovarian cancer drug Zejula, also called niraparib, had been approved by the Food and Drug Administration. Zejula was approved for maintenance treatment of women with several kinds of recurrent ovarian cancer, including epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have undergone chemotherapy. Zejula is the first of a class of cancer drugs called PARP inhibitors to gain approval without being limited to patients with certain biomarkers, such as a BRCA mutation.

  2. #2
    I saw that announcement after the market closed, and was very happy.
    My wife is undergoing treatment for OC, and has one chemo treatment left, a week from today. She's been offered a clinical trial, doing Niriparib as maintenance, after frontline treatment. I want her to do it but she would rather not. I wont force her. Nevertheless its good news to know that its approved should she recur.

    She is BRCA +. Reacted very well to chemo with CA 125 down from 1700 at diagnosis to 4.4 now. Hopeful but cautious.
    Diagnosed at age 64 (in November, 2014), PSA 4.3
    Nov 2014 BX 3 of 12 cores positive original pathology G8. Johns Hopkins second opinion, G6
    Surgery with Dr Ash Tewari Jan 6, 2015
    Post surgical pathology, stage T2c, bilateral disease, upstaged to G7(3+4)
    5% of Prostate involved in Tumor. Organ confined, Margins, SV, lymph nodes (9) all negative, PNI positive
    PSA <.02 until (uh-oh), 2/17 .02. Then 5/17-.033, 8/17-.033, 11/17-.046, 4/18-.060, 6/18-.068, 7/18- .082, 8/18-. 078.
    Decipher score low risk, .37
    ADT/Firmagon started August 2018. SRT to start SEPT 2018. Finished SRT November 2018, Finished ADT Feb 2019
    T=7, PSA <.05

  3. #3
    Moderator Top User jorola's Avatar
    Join Date
    May 2014
    Posts
    1,715
    Another step forward!
    Wife to husband with squamous lung cancer stage 3 b
    dx - April 20/14
    tx started May 20/14 - radiation and chemo
    June 23 - chemo finished
    June 24 - tumor 1/3 the original size
    July 4 - radiation finished
    July 8 - PET scan shows tumor almost gone, lymph nodes back to normal
    Married July 19/14
    Sept 9/14 - repeat can shows tumor continues to shrink more, no new spots. New coughing and pain due to chest infection or side effect of radiation.
    Sept 19/14 - not infection but pneumonitis, place on dex for 4 weeks
    Oct 22/14 - now off of dex and facing even more symptoms of withdrawal
    Dec 16/14 - pretty much nothing left but a scar
    April 7/15 - ditto scan and screw you stats
    Oct 6/15 - more scarring but still cancer still gone
    Feb 2016 -scan the same
    Aug 2016 - more of the same
    Aug 2017 - and ditto
    Aug 2018 - 4 yrs NED

 

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