Olaparib in its tablet formation [OLAP2]

For the 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 have recent FIRST RELAPSE of platinum- sensitive disease and who are now in response following a SECOND platinum- based chemotherapy where the following criteria have been met: There is a separate form OLAP1 for olaparib in tablet formulation as maintenance treatment patients with high grade epithelial stage III or ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum- based FIRST line chemotherapy. There is also a separate form OLAP3 for olaparib in its tablet formulation as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum-based THIRD or subsequent line chemotherapy.

  1. This application is made by and the first cycle of systemic anti-cancer therapy with olaparib tablets will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. 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
  1. This patient has had germline and/or somatic (tumour) BRCA testing.
  2. This patient HAS a documented deleterious or suspected deleterious BRCA mutation(s) in the germline or in the tumour or in both. Please enter below the type of testing done in this patient to determine the presence of deleterious or suspected deleterious BRCA mutation(s):
  • in the germline only or
  • in the tumour (somatic tissue) only or
  • in both germline and somatic tissue.
  1. This patient HAS a documented deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s). Please enter below as to which deleterious or suspected deleterious BRCA mutation(s) the patient has:
  • BRCA 1 mutation or
  • BRCA 2 mutation or a
  • both BRCA1 and BRCA 2 mutations Note: Patients without a deleterious or suspected deleterious BRCA mutation are not eligible to receive olaparib but they are potentially eligible to receive niraparib (form NIR2) or rucaparib (form RUC2).
  1. The patient had disease which was sensitive to initial (first line) platinum-based chemotherapy i.e. the recent FIRST relapse has occurred after a response to initial (first line) platinum-based chemotherapy. its
  2. The patient has recently completed a SECOND platinum-based chemotherapy and has received a minimum of 4 cycles of platinum-based treatment. in
  3. This patient has responded to the recently completed SECOND platinum-based chemotherapy and has achieved a partial or complete response to treatment according to the definitions given below and there is no evidence of IV progressive disease on the post-treatment scan or a rising CA125 level. Please enter below as to which response assessment applies to this patient:
  • achieved a complete response at the end of the 2nd platinum-based chemotherapy i.e. has no measurable or non-measurable disease on the post-chemotherapy scan and the CA125 is normal or
  • achieved a partial response at the end of the 2nd platinum-based chemotherapy i.e. has had 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.
  1. The patient is currently less than 8 weeks from the date of the last infusion of the last cycle of the 2nd platinum-based chemotherapy.
  2. The patient has not previously received any PARP inhibitor unless either niraparib or 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 or olaparib tablets have been received as part of an early access scheme and the patient meets all the other criteria listed here. Please mark below which of the four scenarios applies to this patient:
  • the patient has never previously received a PARP inhibitor or or - the patient has previously received niraparib 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 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 or
  • the patient has previously received olaparib tablets via an early access scheme and the patient meets all the other criteria listed here.
  1. Olaparib tablets will be used as monotherapy.
  2. 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 olaparib.
  1. Olaparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment. Note: this open treatment is different to that of maintenance FIRST line chemotherapy in which treatment duration beyond 2 years is only allowed for certain patients (as outlined in duration olaparib tablets after platinum-based treatment or 14. A formal medical review as to whether maintenance with olaparib should continue not will be scheduled to occur at least by the start of the third cycle of treatment.
  2. No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).
  3. Olaparib in its tablet formulation is to be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 03 October 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA908 (05 July 2023)

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