Difference between revisions of "Pomalidomide (Pomalyst)"

Revision as of 22:06, 14 October 2013

FDA approved 2/8/2013. Also known as Actimid, CC4047, 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

Use of Pomalidomide (Pomalyst) requires participation in the Pomalyst REMS program

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

Clinical trials

Patient drug information

Pomalidomide (Pomalyst) package insert PDF pages 8-9^[1]

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
↑ Cite error: Invalid <ref> tag; no text was provided for refs named Tefferi2009
↑ 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

[insert-1] 1.0 ^1.1 ^1.2 ^1.3 Pomalidomide (Pomalyst) package insert

[2] Pomalidomide (Pomalyst)‎ package insert (locally hosted backup)

[3] Pomalyst manufacturer's website

[Tefferi2009-4] Cite error: Invalid <ref> tag; no text was provided for refs named Tefferi2009

[5] 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

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@@ Line 14: / Line 14: @@
 *[[Light-chain (AL) amyloidosis]]
 *[[Multiple myeloma]]
-*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>
+*[[Myelofibrosis]]
 ==Clinical trials==