Niraparib [NIR2]
Niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who do NOT have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have recent FIRST OR SUBSEQUENT relapse platinum-sensitive disease and who are now in response following a SECOND OR SUBSEQUENT platinum-based chemotherapy where the following criteria have been met: There is a separate form (NIR1) for niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who are in response following a platinum-based SECOND line chemotherapy.
- This application is made by and the first cycle of systemic anti-cancer therapy with niraparib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- This patient has a proven histological diagnosis of predominantly high grade serous or high grade endometrioid or high grade clear cell ovarian, fallopian tube or primary peritoneal carcinoma. Please enter below as to which is the predominant histology in this patient:
- high grade serous adenocarcinoma or
- high grade endometrioid adenocarcinoma or
- high grade clear cell carcinoma
- This patient has had germline and/or somatic (tumour) BRCA testing.
- This patient DOES NOT HAVE a documented deleterious or suspected deleterious BRCA mutation(s) in the germline or in the tumour.
- The patient had disease which was sensitive to the penultimate line of platinum-based chemotherapy (i.e. the disease responded to the line of platinum-based chemotherapy preceding the most recent line of platinum-based chemotherapy).
- The patient has recently completed a further line of platinum-based chemotherapy and has received a minimum of 4 cycles of platinum-based treatment. Please enter below what line of platinum-based treatment was the most recent line of treatment:
- 2nd line or
- 3rd line or
- 4th line or greater
- This patient has responded to the recently completed SECOND OR SUBSEQUENT LINE platinum-based chemotherapy and has achieved a partial or complete response to treatment according to the definitions given below and there a is no evidence of progressive disease on the post-treatment scan or a rising CA125 level. of Please enter below as to which response assessment applies to this patient:
- achieved a complete response at the end of the recent 2nd or subsequent line platinum-based chemotherapy i.e. has no measurable or non-measurable disease on the post-chemotherapy scan and the CA125 is normal
- achieved a partial response at the end of the recent 2nd or subsequent line platinum-based chemotherapy i.e. has had at least a 30% reduction in measurable or non-measurable disease from the start of to the completion of the 2nd platinum-based chemotherapy or the patient has a complete remission on the post-chemotherapy CT scan but the CA125 has not decreased to within the normal range
- The patient is currently less than 8 weeks from the date of the last infusion of the last cycle of the recent 2nd or subsequent line platinum-based chemotherapy.
- The patient has not previously received any PARP inhibitor unless rucaparib via the CDF has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression. Please mark below which of the two scenarios applies to this patient:
- the patient has never previously received a PARP inhibitor or
- the patient has previously received rucaparib via the CDF and this has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression.
- Niraparib will be used as monotherapy.
- The prescribing clinician understands that though the licensed starting dose for niraparib in this 2nd/subsequent line maintenance indication is 300mg daily (as opposed to the licensed starting dose of niraparib in the 1st line maintenance setting usually being 200mg daily), clinical experts informed NICE that the usual starting dose for niraparib in this 2nd/subsequent line maintenance setting is 200mg daily.
- The patient has an ECOG performance status of either 0 or 1. Please enter below as to which ECOG performance status applies to this patient:
- ECOG PS 0 or
- ECOG PS 1. Note: a patient with a performance status of 2 or more is not eligible for niraparib.
- Niraparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
- A formal medical review as to whether maintenance treatment with niraparib should continue or not will be scheduled to occur at least by the start of the second 4-weekly cycle of treatment (in view of the potential need for dose delay or dose reduction in the 2nd cycle of treatment).
- When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended treatment break on account of Covid-19.
- Niraparib is to be otherwise used as set out in its Summary of Product Characteristics.
NHS funded From: 19 July 2022
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.