Lynparza

Olaparib

• Brand(s): Lynparza
• Dosage Form/Strength: 100mg tablets, 150mg tablets
• Updated December 23, 2020, May 2, 2022

For the maintenance treatment of BRCA-mutated, high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who meet ALL the following criteria:

1. Patient has documented mutation in BRCA1 or BRCA2 genes (germline or somatic detected by an approved testing method); AND

2. Patient is using olaparib as maintenance therapy immediately after one course of first line platinum-based chemotherapy in which radiological response (complete or partial) is demonstrated after at least 4 cycles of treatment;
   OR
   Patient is using olaparib as maintenance therapy in relapsed disease after having received more than one prior course of platinum-based chemotherapy in which platinum sensitive disease¹ was demonstrated with one completed treatment course, and there is radiologic response (complete or partial) to the most recently completed course of platinum-based treatment.²

   AND

3. Olaparib is started within 8 weeks of the patient’s final dose of platinum-based chemotherapy² or within 12 weeks³ with restaging to confirm no disease progression if delay of more than 8 weeks since last dose of chemotherapy has occurred; AND

4. Olaparib is being used as monotherapy for maintenance treatment; AND

5. Patient has good performance status.

¹Platinum-sensitive disease is defined as disease progression/recurrence/relapse occurring at least 6 months following completion of a platinum-based chemotherapy in which an initial response had been demonstrated.

²Patients who are unable to use a platinum-based chemotherapy after having demonstrated platinum- sensitive disease to an earlier line of treatment may be considered on a case-by-case basis if they have received at least 4 cycles of a non-platinum treatment, submit documentation for clinically relevant allergies or intolerance to platinum treatment, and meet all other aspects of the above criteria.

³Patients not able to start olaparib within 12 weeks due to extenuating circumstances may be considered on a case-by-case basis if they have no evidence of disease progression, provide information to explain why treatment could not be started within 12 weeks, and meet all other aspects of the above criteria.

Exclusion Criteria: (Patients meeting any of the criteria below will not be funded.)

• Patients who have relapsed after at least one course of platinum-based chemotherapy and have not demonstrated platinum-sensitive disease1.
• Patients who have developed disease progression before start of olaparib maintenance therapy.
• Retreatment with olaparib as maintenance therapy.

Olaparib is not funded when used as combination with chemotherapy.

Recommended dose: 300 mg twice daily for oral tablets

Approval duration: 1 year

Notes:

1. Imaging to rule out disease progression is required for patients delayed in starting maintenance therapy with olaparib by more than 8 weeks or who have stopped therapy for more than 14 days prior to starting or restarting olaparib (Note: CA-125 clinical assessments may be considered case-by-case where imaging is not available).

2. Cancer antigen 125 (CA-125) and clinical assessments should be done at least every 3 to 4 months to monitor for disease reoccurrence or progression.

3. Olaparib will be funded for a maximum of 2 years in the maintenance setting after first line platinum-based therapy if there is no evidence of disease. Olaparib maintenance therapy will be funded ongoing until disease progression or development of unacceptable toxicity to olaparib for those using in relapsed platinum-sensitive disease.

4. Time limited access to olaparib will be provided for patients already on bevacizumab maintenance who wish to switch to olaparib monotherapy as long as other criteria are met and there is no evidence of disease progression on imaging and within 12 weeks of completing chemotherapy.

Renewal Criteria:

Olaparib maintenance therapy after first line platinum-based treatment:
Ongoing funding will be considered until disease progression or development of unacceptable toxicity or up to a maximum of 2 years if there is no evidence of disease.

Olaparib maintenance therapy in relapsed platinum-sensitive disease:
Ongoing funding will be considered until disease progression or development of unacceptable toxicity

Recommended Dose: 300 mg twice daily for oral tablets

Approval duration of renewals: 1 year
(Note that Olaparib will be funded for a maximum of 2 years in the maintenance setting after first line platinum-based therapy if there is no evidence of disease.)

Initiation Criteria:

For the treatment of metastatic castration resistant prostate cancer (mCRPC) in patients meeting all of the following criteria:

1. Olaparib is used in combination with androgen deprivation therapy (ADT)¹; AND

2. Has documentation of the presence of deleterious or suspected deleterious germline and/or somatic mutations in the BRCA 1, BRCA 2 or ATM genes detected using an approved testing method; AND

3. Has metastatic lesions detected on a bone scan, computed tomography (CT), and/or magnetic resonance imaging (MRI); AND

4. Has castration resistant disease based on meeting the following indicia observed while on continuous androgen deprivation therapy (ADT)¹ treatment or post orchiectomy:
   • Castrate serum testosterone levels AND
   • Biochemical progression defined as three (3) prostate-specific antigen (PSA) rises at least 1 week apart, with the last PSA greater than 2ng/mL AND/OR radiographic progression of new or pre-existing disease as determined by the detection of 2 or more lesions on bone scan or presence of new soft tissue lesions by RECIST criteria;

   AND

5. Patient is treatment naïve to olaparib and is using olaparib for mCRPC after experiencing disease progression on an androgen receptor axis targeted therapy (ARAT; e.g. abiraterone, apalutamide, darolutamide, enzalutamide) used at any stage of prostate cancer²; AND

6. Patient has good performance status.

¹ADT is not required for patients with bilateral orchiectomy.
²Refer to EAP funding criteria for the public funding of individual ARATs in various stages of prostate cancer.

Renewal Criteria: Renewals will be considered in patients who have not experienced disease progression or unacceptable toxicity while on olaparib therapy.

Exclusion criteria: (Patients meeting any of the following will not be funded.)

• Patients who have previously progressed on a Polyadenosine 5-diphosphoribose polymerisation (PARP) inhibitor (including olaparib) for mCRPC will not be funded.
• Olaparib will not be funded as combination therapy with another anti-cancer drug for mCRPC (e.g., ARAT, cabazitaxel, or another PARP inhibitor).

Approved Dosage for Initials and Renewals: Up to 600 mg orally daily (Refer to the product monograph for dosing information)

Duration of Approval for initials and renewals: 1 year

Definitions for the purpose of the EAP funding criteria:
ADT – A first generation androgen deprivation therapy (e.g., goserelin, leuprolide, triptorelin, buserelin, degarelix)
ARAT – An androgen receptor axis targeted therapy (e.g., abiraterone, apalutamide, darolutamide, enzalutamide)
PARP – A Polyadenosine 5-diphosphoribose polymerisation inhibitor (e.g., Olaparib, niraparib)

EAP Drug Request Form:

Standard Form for EAP Drug Requests