Lynparza (olaparib)

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Lynparza (olaparib)

Lynparza (olaparib) is a medication used for the treatment of ovarian, fallopian tube, primary peritoneal cancer and breast cancer.

Oncology Breast Cancer, Gynaecological Cancer
Marketing Authorisation Holder AstraZeneca AB
Mode of Action PARP inhibitor
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 50 milligram
Package 448 Capsules

What is Lynparza (olaparib) for?

Lynparza (olaparib) is indicated a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of people with:

  • ovarian, fallopian tube or primary peritoneal cancer

    • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy1,2,3

  • ovarian cancer

    • for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy1

  • breast cancer

    • in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy1.

How does Lynparza (olaparib) work?

PARP enzymes take part in normal cellular functions, including the transcription and repair of DNA. In healthy cells, the reparation of DNA can happen via alternative mechanisms which do not involve the PAPR enzymes. These mechanisms require BRCA1 and BRCA2 proteins. Cancer cells with a mutation in BRCA1 or BRCA2 genes are not able to use these alternative mechanisms to repair their DNA, thus, when the remaining mechanism available (PARP enzymes mediated repair) is blocked by a PARP inhibitor such as olaparib, the damaged DNA in cancer cells cannot be repaired, and as a result, the cancer cells die6,1. In this way, Lynparza (olaparib) helps in the elimination of cancer cells.

BRCA gene mutations occur in approximately 15 to 20% of patients with ovarian cancer4, approximately 20 to 25% of patients with hereditary breast cancers and 5 to 10% of patients with any type of breast cancer8. Although normally BRCA genes are involved in the reparation of damaged DNA and thus work to prevent tumour development when mutations in these genes can lead to the formation of tumours.

Where has Lynparza (olaparib) been approved?

Lynparza (olaparib) was approved by:

  • Food and Drug Administration (FDA), USA:

    • December 19, 20144, with an accelerated approval for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy

    • August 17, 2017, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy9

    • in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting8.


  • European Medical Agency (EMA), European Union (January 9, 20156) and Therapeutic Goods Administration (TGA), Australia (January 7, 20167):

    • monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy2,3.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

Maintenance therapy is the treatment of cancer typically following an initial round of treatment. It is usually given to patients whose cancer is undetectable after previous treatment, and it thus aims at either slowing the cancer's return or lengthening the life of patients with advanced cancer10.

How is Lynparza (olaparib) taken?

The standard dosage of Lynparza (olaparib) capsules is:

  • 400 mg  (8 capsules of 50 mg) taken twice daily2,3

  • Continue treatment until disease progression.

The standard dosage of Lynparza (olaparib) tablets is:

  • 300 mg taken twice daily1

  • Continue treatment until disease progression or unacceptable toxicity.

Please note that we’re unable to source Lynparza (olaparib) tablets due to import regulation restrictions.

Complete information about Lynparza (olaparib) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Lynparza (olaparib) is available as capsules (USA, European Union, Australia) and tablets (USA only). There are differences in the dosing and absorption in the body of each formulation. Tablets and capsules are thus not interchangeable.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Lynparza (olaparib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1,2,3:

  • nausea

  • vomiting

  • diarrhoea

  • fatigue

  • headache

  • dysgeusia (distortion of the sense of taste)

  • abnormalities in blood counts.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,2,3:

  • Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in less than 1.5% of patients and the majority of events had a fatal outcome. All patients had potential contributing factors (previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy)

  • Pneumonitis occurred in less than 1% of patients exposed to Lynparza, and were in some cases fatal.

Use in specific populations

Lynparza (olaparib) could cause fetal harm when administered to a pregnant woman. Lynparza should not be used during pregnancy and reliable contraception should be used during therapy and for 1 month after receiving the last dose of Lynparza. Breastfeeding whilst taking Lynparza is not advised1,2,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient olaparib
Shipping method Controlled room temperature (temperature controlled)
Package 448
Therapeutic Area Oncology
Oncology Breast Cancer, Gynaecological Cancer
Indication Deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (treatment)
Indication Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Ovarian cancer
Administration Oral
Mode of Action PARP inhibitor
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder AstraZeneca AB

Ovarian, fallopian tube, or primary peritoneal cancer (Maintenance treatment)

The Food and Drug Administration's (FDA, USA) approval of Lynparza (olaparib) for the maintenance treatment of ovarian, fallopian tube, or primary peritoneal cancer was based on 2 placebo-controlled studies in patients who were in response to platinum-based therapy. The SOLO-2 study (NCT01874353) involved 295 patients with deleterious or suspected deleterious gBRCA-mutation. The Study-19 (NCT00753545) involved 265 patients who had shown response to initial platinum-based treatment and who had previously received 2 or more platinum based treatments. The European Medical Agency (EMA, European Union) and Therapeutic Goods Administration (TGA, Australia) analysed also a group of 136 patients with identified BRCA mutation2,3.

Results

The main efficacy outcomes were the time patients lived before disease progression (progression-free survival, PFS) in both studies and the overall survival (OS) in Study-19. In the BRCA-mutated group, the time to second subsequent therapy or death (TSST-an approximation of PFS) was analysed2,3.

The median PFS was1:

  • across all patients:
    • 19.1 months for Lynparza (olaparib) vs. 5.5 months for placebo in study SOLO-21
    • 8.4 months for Lynparza (olaparib) vs. 4.8 months for placebo in Study-191
  • in the BRCA-mutated group:
    • 12.2 for Lynparza (olaparib) vs. 4.3 months for placebo in Study-192,3

The median OS was1

  • across all patients:
    • 29.8 months for Lynparza (olaparib) vs. 27.8 months for placebo in Study-19
  • in the BRCA-mutated group:
    • 34.9 months for Lynparza (olaparib) vs. 31.9 months for placebo in Study-19 (not statistically significant)

The median TSST-an approximation of PFS in the BRCA-mutated group was2,3:

  • 23.8 months for Lynparza (olaparib) vs. 15.2 months for placebo in Study-19

Ovarian cancer (Treatment)

The Food and Drug Administration (FDA, USA) approval of Lynparza (olaparib) for ovarian cancer was based on a single-arm study. This study involved 137 patients with measurable, gBRCAm associated ovarian cancer previously treated with three or more prior lines of chemotherapy1.

Results

The major efficacy outcome measures were the objective response rate (ORR) and duration of response (DOR).

The ORR was1:

  • 34% [95% CI: 26, 42]
    • with 2% complete responses

The median DOR was1:

  • 7.9 months [95% CI: 5.6, 9.6]

Breast cancer

The Food and Drug Administration's (FDA, USA)  approval of Lynparza (olaparib) for breast cancer in previously treated patients was based on one open-label study (OlympiAD (NCT02000622)). This study involved a total of 302 previously treated patients with gBRCAm HER2­ negative metastatic breast cancer. Lynparza (olaparib) was compared to a chemotherapy chosen by the healthcare provider, out of capecitabine, eribulin, or vinorelbine (at standard doses)1.

Results

The major efficacy outcome measures were the time patients lived before disease progression (progression-free survival, PFS) and the objective response rate (ORR)1.

A statistically significant improvement in PFS was demonstrated for the Lynparza arm compared to the chemotherapy arm1.

The median PFS was1:

  • 7.0 months with Lynparza (olaparib) vs. 4.2 months with chemotherapy.

The ORR was1:

  • 52% [95 % CI: 44, 60] Lynparza (olaparib) 
  • 23% [95 % CI: 13, 35] with chemotherapy.

1. Summary of Product Characteristics [FDA]: Lynparza (olaparib) - tablets [PDF]
    AstraZeneca, Jan 2018

2. Summary of Product Characteristics [EMA]: Lynparza (olaparib) - capsules [PDF]
    AstraZeneca, Jun. 2017

3. Summary of Product Characteristics [TGA]: Lynparza (olaparib) - capsules [PDF]
     AstraZeneca, Oct. 2016

4. FDA News Release: FDA approves Lynparza to treat advanced ovarian cancer
     Dec 2014

5. Drugs.com. Lynparza
     cited June 2017 

6. EMA. Human Medicines: Lynparza (olaparib),
     cited June 2017 

7. TGA Public Summary
    cited June 2017 

8. FDA News Release: FDA approves first treatment for breast cancer with a certain inherited genetic mutation     Jan 2018

9. FDA approved drugs: FDA approves olaparib tablets for maintenance treatment in ovarian cancer
     Aug 2017 

10. Cancer.net: Understanding maintenance treatment
      cited Feb 2018 


Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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