Difference between revisions of "Carfilzomib (Kyprolis)"
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m (PeterYang moved page Carfilzomib (PR-171) to Carfilzomib (Kyprolis): brand name) |
(FDA approval & extra information) |
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| − | ''' | + | '''FDA approved 7/20/2012'''. Also known as PR-171. |
==General information== | ==General information== | ||
| − | Class/mechanism: Second-generation proteasome inhibitor | + | Class/mechanism: Second-generation proteasome inhibitor that interferes with degradation of ubiquitinated proteins by binding irreversibly to the 20S proteasome, which is the proteolytic core particle inside the 26S proteasome. This disrupts normal homeostatic mechanisms, leading to impaired tumor proliferation, apoptosis/cell death.<ref name="insert">[http://kyprolis.com/Content/pdf/PrescribingInformation.pdf Carfilzomib (Kyprolis) package insert]</ref><ref>[[Media:Carfilzomib.pdf|Carfilzomib (Kyprolis) package insert (locally hosted backup)]]</ref><ref>[http://kyprolis.com Kyprolis manufacturer's website]</ref><ref>[http://kyprolis.com/Content/pdf/PressRelease.pdf Kyprolis 7/20/2012 FDA approval press release]</ref><ref>[http://www.onyx.com/clinical-development/carfilzomib Carfilzomib (Kyprolis) manufacturer's clinical development website]</ref> |
| − | + | ||
| + | Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Clinical trials== | ==Clinical trials== | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT00530816 Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma - PX-171-004]<ref>Vij R, Wang M, Kaufman JL, Lonial S, Jakubowiak AJ, Stewart AK, Kukreti V, Jagannath S, McDonagh KT, Alsina M, Bahlis NJ, Reu FJ, Gabrail NY, Belch A, Matous JV, Lee P, Rosen P, Sebag M, Vesole DH, Kunkel LA, Wear SM, Wong AF, Orlowski RZ, Siegel DS. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma. Blood. 2012 Jun 14;119(24):5661-70. Epub 2012 May 3. [http://bloodjournal.hematologylibrary.org/content/119/24/5661.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22555973 PubMed]</ref> | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT01080391 Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma (ASPIRE)] | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT01302392 A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)] | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT01029054 Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma] | ||
*[http://clinicaltrials.gov/ct2/show/NCT01365559 Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments] | *[http://clinicaltrials.gov/ct2/show/NCT01365559 Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments] | ||
*[http://clinicaltrials.gov/ct2/show/NCT01137747 Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia (AML ALL)] | *[http://clinicaltrials.gov/ct2/show/NCT01137747 Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia (AML ALL)] | ||
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==Patient drug information== | ==Patient drug information== | ||
| − | + | *Brief patient counseling information is available on [http://kyprolis.com/Content/pdf/PrescribingInformation.pdf#page=21 pages 21-22 of the package insert].<ref name="insert"></ref> | |
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 19:34, 21 July 2012
FDA approved 7/20/2012. Also known as PR-171.
General information
Class/mechanism: Second-generation proteasome inhibitor that interferes with degradation of ubiquitinated proteins by binding irreversibly to the 20S proteasome, which is the proteolytic core particle inside the 26S proteasome. This disrupts normal homeostatic mechanisms, leading to impaired tumor proliferation, apoptosis/cell death.[1][2][3][4][5]
Route: IV
Extravasation: no information
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 prescribing information.[1]
Clinical trials
- Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma - PX-171-004[6]
- Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma (ASPIRE)
- A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)
- Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma
- Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments
- Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia (AML ALL)
- Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR)
- Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments
- Carfilzomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Relapsed or Refractory Multiple Myeloma
Patient drug information
- Brief patient counseling information is available on pages 21-22 of the package insert.[1]
References
- ↑ 1.0 1.1 1.2 Carfilzomib (Kyprolis) package insert
- ↑ Carfilzomib (Kyprolis) package insert (locally hosted backup)
- ↑ Kyprolis manufacturer's website
- ↑ Kyprolis 7/20/2012 FDA approval press release
- ↑ Carfilzomib (Kyprolis) manufacturer's clinical development website
- ↑ Vij R, Wang M, Kaufman JL, Lonial S, Jakubowiak AJ, Stewart AK, Kukreti V, Jagannath S, McDonagh KT, Alsina M, Bahlis NJ, Reu FJ, Gabrail NY, Belch A, Matous JV, Lee P, Rosen P, Sebag M, Vesole DH, Kunkel LA, Wear SM, Wong AF, Orlowski RZ, Siegel DS. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma. Blood. 2012 Jun 14;119(24):5661-70. Epub 2012 May 3. link to original article PubMed