Difference between revisions of "Olaparib (Lynparza)"
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*8/17/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572143.htm Granted regular approval] for the maintenance treatment of adult patients with recurrent [[Ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]], who are in a complete or partial response to [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Approval expanded to maintenance after second-line therapy)'' | *8/17/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572143.htm Granted regular approval] for the maintenance treatment of adult patients with recurrent [[Ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]], who are in a complete or partial response to [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Approval expanded to maintenance after second-line therapy)'' | ||
*12/19/2018: Approved for the maintenance treatment of adult patients with deleterious or suspected deleterious [[Biomarkers#Germline|germline]] or [[Biomarkers#Somatic|somatic]] [[Biomarkers#BRCA|BRCA]]-[[Biomarkers#Alterations|mutated]] (gBRCAm or sBRCAm) advanced [[Ovarian cancer|epithelial ovarian, fallopian tube or primary peritoneal cancer]] who are in complete or partial response to first-line [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Approval expanded to maintenance after first-line therapy)'' | *12/19/2018: Approved for the maintenance treatment of adult patients with deleterious or suspected deleterious [[Biomarkers#Germline|germline]] or [[Biomarkers#Somatic|somatic]] [[Biomarkers#BRCA|BRCA]]-[[Biomarkers#Alterations|mutated]] (gBRCAm or sBRCAm) advanced [[Ovarian cancer|epithelial ovarian, fallopian tube or primary peritoneal cancer]] who are in complete or partial response to first-line [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Approval expanded to maintenance after first-line therapy)'' | ||
| − | *5/8/2020: Approval expanded to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced [[Ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. ''(Approval expanded to combination maintenance after first-line therapy)'' | + | *5/8/2020: Approval expanded to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced [[Ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with [[Biomarkers#HRD|homologous recombination deficiency positive status]] defined by either a deleterious or suspected deleterious [[Biomarkers#BRCA|BRCA]] [[Biomarkers#Alterations|mutation]], and/or [[Biomarkers#Genomic_instability|genomic instability]]. ''(Approval expanded to combination maintenance after first-line therapy)'' |
===[[Pancreatic cancer|gBRCAm Pancreatic cancer]]=== | ===[[Pancreatic cancer|gBRCAm Pancreatic cancer]]=== | ||
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===[[Prostate cancer]]=== | ===[[Prostate cancer]]=== | ||
| − | *5/19/2020: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-hrr-gene-mutated-metastatic-castration-resistant-prostate-cancer Approved] for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant [[prostate cancer]] (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. ''(New disease entity)'' | + | *5/19/2020: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-hrr-gene-mutated-metastatic-castration-resistant-prostate-cancer Approved] for adult patients with deleterious or suspected deleterious germline or somatic [[Biomarkers#HRD|homologous recombination repair (HRR) gene-mutated]] metastatic castration-resistant [[prostate cancer]] (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. ''(New disease entity)'' |
==Also known as== | ==Also known as== | ||
Revision as of 00:23, 13 April 2021
General information
Class/mechanism: PARP (poly-ADP (adenosine diphosphate)–ribose polymerase) inhibitor. PARP participates in the alternative base-excision repair pathway that helps to repair single-strand DNA breaks. PARP is involved in normal cellular homeostasis processes during DNA transcription and cell cycle regulation. By inhibiting PARP1, PARP2, and PARP3, olaparib leads to the accumulation of single-strand breaks. In patients with a concurrent BRCA1/BRCA2 mutation, in which there are also defects in homologous recombination double strand DNA repair, this inhibition of PARP enzymatic activity and formation of the PARP-DNA complex can lead to irrecoverable DNA damage and cell death.[1][2][3]
[4]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.[1]
Diseases for which it is used
Patient drug information
- Olaparib (Lynparza) package insert[1]
- Olaparib (Lynparza) patient drug information (Chemocare)[5]
- Olaparib (Lynparza) patient drug information (UpToDate)[6]
History of changes in FDA indication
gBRCAm Breast cancer
- 1/12/2018: Granted regular approval for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. (New disease entity)
Ovarian cancer
- 12/19/2014: Granted initial accelerated approval as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
- 8/17/2017: Granted regular approval 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 chemotherapy. (Approval expanded to maintenance after second-line therapy)
- 12/19/2018: Approved 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 chemotherapy. (Approval expanded to maintenance after first-line therapy)
- 5/8/2020: Approval expanded to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. (Approval expanded to combination maintenance after first-line therapy)
gBRCAm Pancreatic cancer
- 12/27/2019: Approved for the maintenance treatment of adult patients 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. (New disease entity)
Prostate cancer
- 5/19/2020: Approved for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. (New disease entity)
Also known as
- Code names: AZD2281, AZD-2281, KU-0059436
- Brand name: Lynparza
References
- ↑ 1.0 1.1 1.2 Olaparib (Lynparza) package insert
- ↑ Olaparib (Lynparza) package insert (locally hosted backup)
- ↑ Lynparza manufacturer's website
- ↑ 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. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. Epub 2009 Jun 24. link to original article PubMed
- ↑ Olaparib (Lynparza) patient drug information (Chemocare)
- ↑ Olaparib (Lynparza)patient drug information (UpToDate)