GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer
- Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency (HRD)
- Zejula is now the only, once-daily PARP inhibitor approved as monotherapy treatment for recurrent ovarian cancer beyond those with a?BRCA?mutation in both the recurrent maintenance and late-line treatment settings
October 23, 2019 05:36 PM Eastern Daylight Time
PHILADELPHIA--(BUSINESS WIRE)--GlaxoSmithKline (LSE/NYSE: GSK) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor 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 homologous recombination deficiency (HRD) positive status defined by either:
- A deleterious or suspected deleterious?BRCA?mutation, or
- genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy. Patient selection is based on an FDA-approved companion diagnostic for Zejula.
- tBRCA+ platinum-sensitive disease, ORR of 39% (95% CI, 17,64);
- tBRCA+ platinum-resistant disease, ORR of 29% (95% CI, 11,52);
- tBRCA+ platinum-refractory disease, ORR of 19% (95% CI, 4,46); or
- non-BRCA?mut, GIS-positive, platinum-sensitive disease, ORR of 20% (95% CI, 8,37).
- Weakness
- Feeling tired
- Weight loss
- Frequent infections
- Fever
- Shortness of breath
- Blood in urine or stool
- Bruising or bleeding more easily
- Have heart problems
- Have high blood pressure
- Are pregnant or plan to become pregnant. Zejula may harm an unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, you should use effective birth control (contraception) during treatment with Zejula and for 6 months after taking the last dose of Zejula
- If you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with Zejula
- You should tell your doctor right away if you become pregnant
- Are breastfeeding or plan to breastfeed
- Zejula may harm your baby. You should not breastfeed your baby during treatment with Zejula and for 1 month after taking the last dose of Zejula
- Heart not beating regularly
- Nausea
- Constipation
- Vomiting
- Pain in the stomach area
- Mouth sores
- Diarrhea
- Indigestion or heartburn
- Dry mouth
- Tiredness
- Loss of appetite
- Urinary tract infection
- Shortness of breath
- Cough
- Rash
- Changes in liver function or other blood tests
- Pain in your joints, muscles, and back
- Headache
- Dizziness
- Change in the way food tastes
- Trouble sleeping
- Anxiety
- Sore throat
- Changes in the amount or color of your urine