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Revision as of 14:34, 24 November 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 454236703 of page Olaparib for the Chem/Drugbox validation project (updated: 'ChEMBL', 'CAS_number').  Latest revision as of 11:10, 7 September 2024 edit Citation bot (talk | contribs)Bots5,429,027 edits Added date. | Use this bot. Report bugs. | Suggested by Whywhenwhohow | #UCB_webform 634/962 
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{{Short description|Chemical compound (cancer therapy drug)}}
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{{Drugbox
{{Use dmy dates|date=December 2019}}
| verifiedrevid = 454235249
{{Infobox drug
| IUPAC_name = 4-carbonyl) -4-fluorophenyl]methyl(2H)phthalazin-1-one
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| image = Olaparib.png
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| width = 200
| verifiedrevid = 462264805
| image = Olaparib.svg
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| caption =


<!--Clinical data--> <!-- Clinical data -->
| tradename = | pronounce =
| tradename = Lynparza, others
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| Drugs.com = {{drugs.com|monograph|olaparib}}
| pregnancy_US = <!-- A / B / C / D / X -->
| MedlinePlus = a614060
| pregnancy_category =
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| legal_status = Investigational
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| ATC_suffix = XK01
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<!--Pharmacokinetic data--> <!-- Legal status -->
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| legal_US = Rx-only
| legal_US_comment = <ref name="Lynparza capsule PI" /><ref name="Lynparza FDA label" />
| legal_EU = Rx-only
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<!-- Identifiers -->
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| CAS_number = 763113-22-0
| CAS_supplemental =
| PubChem = 23725625 | PubChem = 23725625
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| PDB_ligand = 09L
| synonyms = AZD-2281, MK-7339, KU0059436

<!-- Chemical and physical data -->
| IUPAC_name = 4-carbonyl) -4-fluorophenyl]methyl(2H)phthalazin-1-one
| C=24 | H=23 | F=1 | N=4 | O=3
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| density_notes =
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| melting_high =
| molecular_weight = 435.08 g/mol
| melting_notes =
| smiles = c4cccc2c4c(nnc2=O)Cc(ccc1F)cc1C(=O)N3CCN(CC3)C(=O)C5CC5
| boiling_point =
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}} }}

'''Olaparib''', sold under the brand name '''Lynparza''', is a medication for the maintenance treatment of BRCA-mutated advanced ovarian cancer in adults. It is a ], inhibiting ] (PARP), an enzyme involved in ]. It acts against cancers in people with hereditary ] or ] mutations, which include some ovarian, breast, and prostate cancers.<ref name="Fong2009">{{cite journal | vauthors = Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS | display-authors = 6 | title = Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers | journal = The New England Journal of Medicine | volume = 361 | issue = 2 | pages = 123–134 | date = July 2009 | pmid = 19553641 | doi = 10.1056/NEJMoa0900212 | doi-access = free }}</ref>

In December 2014, olaparib was approved for use as a single agent by the ] (EMA) in the European Union and by the ] (FDA) in the United States.<ref name="EMA">{{cite web |url=https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003726/WC500180153.pdf |title=Lynparza (olaparib): An overview of Lynparza and why it is authorised in the EU |website=] (EMA) |access-date=13 April 2020 |archive-date=16 March 2018 |archive-url=https://web.archive.org/web/20180316181142/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003726/WC500180153.pdf |url-status=dead }}</ref><ref name="Lynparza EPAR">{{cite web | title=Lynparza EPAR | website=] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza | access-date=13 April 2020}}</ref><ref name="FDA approval">{{cite web | title=Drug Approval Package: Lynparza (olaparib) Capsules NDA #206162 | website=U.S. ] (FDA) | date=22 January 2015 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000TOC.cfm | access-date=13 April 2020}}</ref><ref name="FDAapp">{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm |title=FDA approves Lynparza to treat advanced ovarian cancer|website=U.S. ] (FDA) | date=19 December 2014 | archive-url=https://web.archive.org/web/20141219215656/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm | archive-date=19 December 2014 | url-status=dead | access-date=30 December 2019 }} {{PD-notice}}</ref>

== Medical uses ==
Olaparib is ] to treat ], ], ], ], ], and ].<ref name="Lynparza FDA label" /><ref name="Lynparza EPAR" /><ref name="FDA 20220311">{{cite web | title=FDA approves olaparib for adjuvant treatment of high-risk early breast | website=U.S. ] (FDA) | date=11 March 2022 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-adjuvant-treatment-high-risk-early-breast-cancer | access-date=14 March 2022}} {{PD-notice}}</ref>

==Side effects==
Side effects include ] effects such as ], ], and ]; ]; muscle and ]; and low ] such as ], with occasional ].<ref name="Lynparza capsule PI"/> ] was sometimes seen in clinical trials which used doses higher than the approved schedule.<ref name="Fong2009"/>

==Mechanism of action==
Olaparib acts as an inhibitor of the ] ] (PARP), and is termed a ]. ] mutations may be genetically predisposed to development of some forms of cancer, and may be resistant to other forms of cancer treatment. However, these cancers sometimes have a unique vulnerability, as the cancer cells have increased reliance on PARP to repair their DNA and enable them to continue dividing. This means that drugs which selectively inhibit PARP may be of benefit if the cancers are susceptible to this treatment.<ref>{{cite web|url=https://www.emea.europa.eu/pdfs/human/comp/opinion/51078707en.pdf|title=Olaparib for the treatment of ovarian cancer.|website=europa.eu}}</ref><ref name="pmid18800822">{{cite journal | vauthors = Menear KA, Adcock C, Boulter R, Cockcroft XL, Copsey L, Cranston A, Dillon KJ, Drzewiecki J, Garman S, Gomez S, Javaid H, Kerrigan F, Knights C, Lau A, Loh VM, Matthews IT, Moore S, O'Connor MJ, Smith GC, Martin NM | display-authors = 6 | title = 4--2H-phthalazin-1-one: a novel bioavailable inhibitor of poly(ADP-ribose) polymerase-1 | journal = Journal of Medicinal Chemistry | volume = 51 | issue = 20 | pages = 6581–6591 | date = October 2008 | pmid = 18800822 | doi = 10.1021/jm8001263 }}</ref>

==History==
Olaparib was developed and first dosed into patients by the UK-based biotechnology company, KuDOS Pharmaceuticals, that was founded by ] of ], UK.<ref>{{Cite web |vauthors=Arney K |date=24 October 2014 |url=https://scienceblog.cancerresearchuk.org/2014/10/24/coming-ever-closer-first-parp-inhibitor-on-track-to-be-licensed-in-europe/ |title=Coming ever closer – first PARP inhibitor licensed in Europe |publisher=Cancer Research UK |type=science blog |access-date=11 June 2019 |archive-date=30 March 2019 |archive-url=https://web.archive.org/web/20190330134059/https://scienceblog.cancerresearchuk.org/2014/10/24/coming-ever-closer-first-parp-inhibitor-on-track-to-be-licensed-in-europe/ |url-status=dead }}</ref><ref>{{Cite web|url=https://www.icr.ac.uk/news-archive/kudos-pharmaceuticals-first-patient-treated-with-new-anti-cancer-agent |title=KuDOS Pharmaceuticals: First Patient Treated with New Anti-cancer Agent |publisher=Institute of Cancer Research |type=press release |date=25 July 2005}}</ref><ref>{{Cite web|url=https://medium.com/@CRUKresearch/olaparib-realising-the-promise-of-synthetic-lethality-f5f61d84ad99 |title=Olaparib: realising the promise of synthetic lethality |publisher=Cancer Research UK|date=16 July 2015}}</ref><ref>{{cite web|url=https://www.cancerresearchuk.org/funding-for-researchers/research-features/2020-09-24-parp-inhibitors-halting-cancer-by-halting-dna-repair|title=PARP inhibitors: Halting cancer by halting DNA repair|publisher=Cancer Research UK|date=24 September 2020}}</ref> Since KuDOS was acquired by ] in 2006, the drug has undergone clinical development by ] and ]<ref>{{Cite web|url=https://www.cancer.gov/news-events/cancer-currents-blog/2018/ovarian-cancer-olaparib-maintenance-therapy| work = National Cancer Institute | title = Olaparib after Initial Treatment Delays Ovarian Cancer Progression | date = 20 November 2018 }}</ref>

In December 2014, the US ] (FDA) and the ] (EMA) approved olaparib as monotherapy.<ref name="Lynparza capsule PI"/><ref name="FDAapp"/><ref name="FDA approval" /><ref name="EMA"/><ref name="Lynparza EPAR" /> The FDA approval is in ] BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy.<ref name="Lynparza capsule PI"/><ref>{{cite journal | vauthors = Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J | title = Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer | journal = The Cochrane Database of Systematic Reviews | volume = 2022 | issue = 2 | pages = CD007929 | date = February 2022 | pmid = 35170751 | pmc = 8848772 | doi = 10.1002/14651858.CD007929.pub4 }}</ref> The EMA public assessment report, which utilized the same phase II trial data, made reference to both "high grade serous ovarian cancers" and to the use of olaparib "not later than 8 weeks after a course of ]-based medicines, when the tumour was diminishing in size or had completely disappeared".<ref name="EMA"/>

Olaparib in combination with ] demonstrated substantial clinical activity in relapsed ].<ref>{{cite journal | vauthors = Farago AF, Yeap BY, Stanzione M, Hung YP, Heist RS, Marcoux JP, Zhong J, Rangachari D, Barbie DA, Phat S, Myers DT, Morris R, Kem M, Dubash TD, Kennedy EA, Digumarthy SR, Sequist LV, Hata AN, Maheswaran S, Haber DA, Lawrence MS, Shaw AT, Mino-Kenudson M, Dyson NJ, Drapkin BJ | display-authors = 6 | title = Combination Olaparib and Temozolomide in Relapsed Small-Cell Lung Cancer | journal = Cancer Discovery | volume = 9 | issue = 10 | pages = 1372–1387 | date = October 2019 | pmid = 31416802 | pmc = 7319046 | doi = 10.1158/2159-8290.CD-19-0582 | doi-access = free }}</ref>

The FDA approval was for germline BRCA mutated (gBRCAm) advanced ] that has received three or more prior lines of chemotherapy.<ref name="Lynparza capsule PI">{{cite web | title=Lynparza- olaparib capsule | website=DailyMed | date=27 September 2018 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e31a6a9-864f-4aba-8085-37ee1ddcd499 | access-date=30 December 2019}}</ref> In January 2018, olaparib became the first PARP inhibitor to be approved by the FDA for gBRCAm metastatic breast cancer.

In breast cancer, olaparib is approved for gBRCAm ]-negative metastatic breast cancer patients who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. If patients have hormone receptor positive cancer, they should have received endocrine therapy where appropriate.<ref name="Lynparza FDA label">{{cite web | title=Lynparza- olaparib tablet, film coated | website=DailyMed | date=1 June 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa | access-date=30 December 2019}}</ref> This approval was based on the OlympiAD randomised phase III trial, which showed a progression-free survival benefit for patients treated with olaparib compared to conventional chemotherapy.<ref name="pmid28578601">{{cite journal | vauthors = Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P | display-authors = 6 | title = Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation | journal = The New England Journal of Medicine | volume = 377 | issue = 6 | pages = 523–533 | date = August 2017 | pmid = 28578601 | doi = 10.1056/NEJMoa1706450 | doi-access = free | hdl = 11577/3243125 | hdl-access = free }}</ref><ref name="FDAapp_breast">{{cite web | title=FDA approves olaparib for germline BRCA-mutated metastatic breast cancer | website=U.S. ] (FDA) | date=12 January 2018 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-germline-brca-mutated-metastatic-breast-cancer | access-date=13 April 2020}}</ref>

In August 2017, olaparib tablets were approved in the United States for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.<ref name="FDA PR 20170817">{{cite web | title=FDA approves olaparib tablets for maintenance treatment in ovarian cancer | website=U.S. ] (FDA) | date=17 August 2017 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-tablets-maintenance-treatment-ovarian-cancer | access-date=13 April 2020}} {{PD-notice}}</ref><ref name="FDA tablet approval">{{cite web | title=Drug Approval Package: Lynparza tablets (olaparib) | website=U.S. ] (FDA) | date=17 August 2017 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558_toc.cfm | access-date=13 April 2020}}</ref> The formulation was changed from capsules to tablets and the capsules were phased out in the United States.<ref name="FDA PR 20170817" /> The capsules and tablets are not interchangeable.<ref name="FDA PR 20170817" />

The approval in the maintenance setting was based on two randomized, placebo-controlled, double-blind, multicenter trials in patients with recurrent ovarian cancers who were in response to platinum-based therapy.<ref name="FDA PR 20170817" /> SOLO-2 (NCT01874353) randomized 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer (2:1) to receive olaparib tablets 300&nbsp;mg orally twice daily or placebo.<ref name="FDA PR 20170817" /> SOLO-2 demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) in patients randomized to olaparib compared with those who received placebo, with a hazard ratio (HR) of 0.30 (95% CI: 0.22, 0.41; p<0.0001).<ref name="FDA PR 20170817" /> Study 19 (NCT00753545) randomized 265 patients regardless of BRCA status (1:1) to receive olaparib capsules 400&nbsp;mg orally twice daily or placebo.<ref name="FDA PR 20170817" /> Study 19 demonstrated a statistically significant improvement in investigator-assessed PFS in patients treated with olaparib vs. placebo with a HR of 0.35.<ref name="FDA PR 20170817" />

In January 2018, olaparib was approved in the United States for the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.<ref name="FDA PR 20180112">{{cite press release | title=FDA approves first treatment for breast cancer with a certain inherited genetic mutation | website=U.S. ] (FDA) | date=12 January 2018 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-breast-cancer-certain-inherited-genetic-mutation | archive-url=https://web.archive.org/web/20191231073007/https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-breast-cancer-certain-inherited-genetic-mutation | archive-date=31 December 2019 | url-status=live | access-date=30 December 2019}} {{PD-notice}}</ref> Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.<ref name="FDA PR 20180112" />

In December 2018, olaparib was approved in the United States for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.<ref name="FDA PR 20181226">{{cite web | title=FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based | website=U.S. ] (FDA) | date=26 December 2018 | url=https://www.fda.gov/drugs/fda-approved-olaparib-lynparza-astrazeneca-pharmaceuticals-lp-maintenance-treatment-adult-patients | archive-url=https://web.archive.org/web/20191231072927/https://www.fda.gov/drugs/fda-approved-olaparib-lynparza-astrazeneca-pharmaceuticals-lp-maintenance-treatment-adult-patients | archive-date=31 December 2019 | url-status=live | access-date=30 December 2019}} {{PD-notice}}</ref> Adults with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.<ref name="FDA PR 20181226" /> Approval was based on SOLO-1 (NCT01844986), a randomized, double-blind, placebo-controlled, multi-center trial that compared the efficacy of olaparib with placebo in patients with BRCA-mutated (BRCAm) advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy.<ref name="FDA PR 20181226" /> Patients were randomized (2:1) to receive olaparib tablets 300&nbsp;mg orally twice daily (n=260) or placebo (n=131).<ref name="FDA PR 20181226" />

In December 2019, olaparib was approved for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.<ref name="FDA 20191227">{{cite web | title=FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma | website=U.S. ] (FDA) | date=27 December 2019 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-gbrcam-metastatic-pancreatic-adenocarcinoma | access-date=31 December 2019}} {{PD-notice}}</ref> The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with pancreatic cancer for treatment with olaparib based upon the identification of deleterious or suspected deleterious ]s in BRCA1 or BRCA2 genes.<ref name="FDA 20191227" /> Efficacy was investigated in POLO (NCT02184195), a double-blind, placebo-controlled, multi-center trial that randomized (3:2) 154 patients with gBRCAm metastatic pancreatic adenocarcinoma to olaparib 300&nbsp;mg orally twice daily or placebo until disease progression or unacceptable toxicity.<ref name="FDA 20191227" />

In March 2022, olaparib was approved for the adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.<ref name="FDA 20220311" />

In April 2023, the National Health Service (NHS) in Wales and England will administer Olaparib to cancer patients as part of its targeted therapy. This drug is developed to target specific malignancies connected to defective breast cancer (BRCA) gene variants.
Through this move, 800 people—300 women with early breast cancer and 500 men with advanced prostate cancer will receive this drug for free.
Andrew Tutt, a breast oncology professor at King's College London and Institute of Cancer Research said that this treatment increases patients’ chances of surviving breast cancer. It can also extend a person’s life in cases of prostate cancer. Tutt added that these were previously unattainable.
<ref>{{Cite news|url=https://www.bbc.com/news/health-65188865 |title=Olaparib: Drug to treat inherited cancers offered on NHS in England and Wales |work=BBC}}</ref>

== References ==
{{reflist}}

{{Chemotherapeutic agents}}
{{AstraZeneca}}
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]
]
]
]
]
]
]