Difference between revisions of "Pomalidomide (Pomalyst)"
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| − | ''' | + | '''FDA approved 2/8/2013'''. Also known as Actimid, CC-4047, or 3-amino-thalidomide. |
==General information== | ==General information== | ||
| − | Class/mechanism: Second-generation immunomodulatory drug (IMiD) | + | Class/mechanism: Second-generation immunomodulatory drug (IMiD)--a [[Thalidomide (Thalomid)|thalidomide]] analogue--with antineoplastic activity. Pomalidomide has been shown to inhibit growth and induce apoptosis of hematopoietic tumor cells, enhance natural killer (NK) and T-cell cell-mediated immunity, and suppress monocyte production of pro-inflammatory cytokines tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6).<ref name="insert">[http://www.pomalyst.com/docs/prescribing_information.pdf Pomalidomide (Pomalyst) package insert]</ref><ref>[[Media:Pomalidomide.pdf | Pomalidomide (Pomalyst) package insert (locally hosted backup)]]</ref><ref>[http://www.pomalyst.com/ Pomalyst manufacturer's website]</ref> |
| − | + | Route: PO | |
<br>Extravasation: n/a | <br>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 [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 | + | 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> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
| − | *Myelofibrosis | + | *Myelofibrosis<ref name="Tefferi2009">Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. [http://jco.ascopubs.org/content/27/27/4563.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/19652059 PubMed]</ref> |
==Clinical trials== | ==Clinical trials== | ||
| Line 18: | Line 18: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | + | *[http://www.pomalyst.com/docs/prescribing_information.pdf#page=8 Pomalidomide (Pomalyst) package insert PDF pages 8-9]<ref name="insert"></ref> | |
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2/8/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338895.htm FDA approved] for treatment of [[multiple myeloma]] in patients who received at least two previous therapies including [[Lenalidomide (Revlimid)]] and [[Bortezomib (Velcade)]] who have progressive disease within 60 days of the completion of the last therapy<ref name="insert"></ref> | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drug index]] | ||
| + | [[Category:Chemotherapy]] | ||
| + | [[Category:Immunomodulatory drugs (IMiDs)]] | ||
| + | [[Category:Multiple myeloma medications]] | ||
| + | [[Category:Drugs FDA approved in 2013]] | ||
Revision as of 21:20, 11 February 2013
FDA approved 2/8/2013. Also known as Actimid, CC-4047, or 3-amino-thalidomide.
General information
Class/mechanism: Second-generation immunomodulatory drug (IMiD)--a thalidomide analogue--with antineoplastic activity. Pomalidomide has been shown to inhibit growth and induce apoptosis of hematopoietic tumor cells, enhance natural killer (NK) and T-cell cell-mediated immunity, and suppress monocyte production of pro-inflammatory cytokines tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6).[1][2][3]
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 prescribing information.[1]
Diseases for which it is used
- Multiple myeloma
- Myelofibrosis[4]
Clinical trials
- Pomalidomide is active in the treatment of anemia associated with myelofibrosis[4]
- MM-003: Pomalidomide in Combination with Low-Dose Dexamethasone: Demonstrates a Significant Progression Free Survival and Overall Survival Advantage, in Relapsed/Refractory MM: A Phase 3, Multicenter, Randomized, Open-Label Study[5]
Patient drug information
History of changes in FDA indication
- 2/8/2013: FDA approved for treatment of multiple myeloma in patients who received at least two previous therapies including Lenalidomide (Revlimid) and Bortezomib (Velcade) who have progressive disease within 60 days of the completion of the last therapy[1]
References
- ↑ 1.0 1.1 1.2 1.3 Pomalidomide (Pomalyst) package insert
- ↑ Pomalidomide (Pomalyst) package insert (locally hosted backup)
- ↑ Pomalyst manufacturer's website
- ↑ 4.0 4.1 Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed
- ↑ Meletios A. Dimopoulos, MD, Martha Q Lacy, MD, Philippe Moreau, MD, Katja C Weisel, MD, Kevin W. Song, MD, FRCPC, Michel Delforge, MD, PhD, Lionel Karlin, MD, Hartmut Goldschmidt, MD, Anne Banos, MD, Albert Oriol, MD, Xin Yu, PhD, Lars Sternas, MD, Christian J. Jacques, MD, Mohamed Zaki, MD and Jesús F San Miguel, MD, PhD. Pomalidomide in Combination with Low-Dose Dexamethasone: Demonstrates a Significant Progression Free Survival and Overall Survival Advantage, in Relapsed/Refractory MM: A Phase 3, Multicenter, Randomized, Open-Label Study. 2012 ASH Annual Meeting abstract LBA-6. link to abstract