Pomalidomide (Pomalyst)

General information

Class/mechanism: Second-generation immunomodulatory drug (IMiD)--a thalidomide analog--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).

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, or the prescribing information.

Toxicity management

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

Diseases for which it is established

• Multiple myeloma

Diseases for which it is used

• Hereditary hemorrhagic telangiectasia
• Kaposi sarcoma
• Light-chain (AL) amyloidosis
• Myelofibrosis

Patient drug information

• Pomalidomide (Pomalyst) package insert
• Pomalidomide (Pomalyst) patient drug information (Chemocare)
• Pomalidomide (Pomalyst) patient drug information (UpToDate)

History of changes in FDA indication

Kaposi sarcoma

• 2020-05-14: Accelerated approval for adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy. (New disease entity with prior treatment requirement; based on NCI 12-C-0047)
• 2020-05-14: Accelerated approval for Kaposi sarcoma in adult patients who are HIV-negative. (New disease entity; based on NCI 12-C-0047)

Multiple myeloma

• 2013-02-08: Accelerated approval 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. (Based on CC-4047-MM-002)
  • 2015-04-23: Converted to regular approval for use in combination with low-dose dexamethasone, for the treatment of patients with relapsed and/or refractory multiple myeloma who have received at least 2 previous lines of therapy, including lenalidomide and a proteasome inhibitor, and whose disease progressed during or within 60 days of completing the last therapy. (Based on NIMBUS)

History of changes in EMA indication

• 2013-08-05: Initial marketing authorisation

History of changes in Health Canada indication

• 2014-01-20: Initial notice of compliance

History of changes in PMDA indication

• 2015-03-26: Initial approval for the treatment of relapsed or refractory multiple myeloma.

Also known as

• Code names: CC-4047
• Generic name: 3-amino-thalidomide
• Brand names: Actimid, Ibipolid, Imnovid, Pomalid, Pomalyst