Lynparza (olaparib)

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Lynparza (olaparib)

How to buy Lynparza: You can order Lynparza (olaparib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer AstraZeneca
Disease Ovarian Cancer
Indication Deleterious BRCA mutation associated with advanced ovarian cancer
Mode of Action PARP inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 50 mg

Who is olaparib for?

Lynparza (olaparib) is indicated as monotherapy for patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer [1][2][3] who are in response (complete response or partial response) after platinum-based chemotherapy [2][3].

Recommended dose

Complete information about Lynparza (olaparib) dosage and administration can be found here [1][2][3]
The standard dosage is:
  • 400 mg  (8 capsules) taken twice daily.
Continue treatment until disease progression or unacceptable toxicity.
Consult your treating doctor for personalised dosing.

What is olaparib and how does it work?

Lynparza (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer [1][2][3] who are in response (complete response or partial response) after platinum-based chemotherapy [2][3].

Approximately 15 to 20 % of patients with ovarian cancer have a BRCA gene mutation. BRCA genes are involved in the reparation of damaged DNA and normally work to prevent tumour development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Lynparza (olaparib) is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slowdown or stoppage of tumour growth [4].

What is olaparib's approval status?

Lynparza (olaparib) was approved by:
  • FDA (USA) on December 19, 2014 [5]
  • EMA (EU) on January 9, 2015 [6]
  • TGA (AUS) on October 13, 2016 [7]
for deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer.

The FDA approval was based on a single-arm study involving 137 patients with measurable, gBRCAm associated ovarian cancer treated with three or more prior lines of chemotherapy. The objective response rate (ORR) was 34 % (95 CI: 26, 42) with 2 % complete response and a median duration of response (mDOR) of 7.9 months (95 % CI: 5.6, 9.6) [1].

The EMA and TGA approvals were based on a double-blind placebo-controlled trial which involved 136 ovarian cancer patients with detected BRCA mutation who were in response following completion of two or more previous platinum-containing chemotherapy. The progression-free survival (PFS) was 12.2 months in the olaparib group and 4.3 in the placebo group. There was no statistically significant difference in the overall survival [2][3].
The most common side effects are fatigue (tiredness), nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), headache, taste disturbances, decreased appetite, dizziness, anaemia (low red blood cell counts), lymphopenia and neutropenia (low counts of certain types of white blood cell), mean corpuscular volume elevation (increase in the average size of red blood cells) and increase in creatinine (high levels of creatinine in blood indicates problems with kidney function) [6].
References
[1] Summary of Product Characteristics [FDA]: Lynparza (olaparib), Astra Zeneca, Oct. 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206162s002lbl.pdf
[2] Summary of Product Characteristics [EMA]: Lynparza (olaparib), Astra Zeneca, Jun. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003726/WC500180151.pdf
[3] Summary of Product Characteristics [TGA]: Lynparza (olaparib), Astra Zeneca, Oct. 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-01055-1
[4] FDA News Release: FDA grants accelerated approval to new treatment for advanced ovarian cancer, 19/12/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm
[5] Drugs.com. Lynparza, (last update: 15/11/2016), cited on 20/06/2017.
https://www.drugs.com/lynparza.html
[6] EMA. Human Medicines: Lynparza (olaparib), 9/01/2015 (last update: 14/06/2017), cited on 20/06/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003726/human_med_001831.jsp&mid=WC0b01ac058001d124
[7] TGA Public Summary. 13/10/2016, cited on 21/06/2017.
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=17BBB1B546D535AECA25804B003C9CFF&agid=(PrintDetailsPublic)&actionid=1









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