Difference between revisions of "Pomalidomide (Pomalyst)"
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[[Category:Drugs FDA approved in 2013]] | [[Category:Drugs FDA approved in 2013]] | ||
Revision as of 22:15, 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
- 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
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedTefferi2009 - ↑ 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