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Lenalidomide hydrochloride hydrate is the active substance in medicines such as Lenalidomide Krka and the reference product Revlimid. It is an immunomodulating agent classified under ATC code L04AX04.[3]
Lenalidomide hydrochloride hydrate is an immunomodulating agent. The European Medicines Agency (EMA) describes the active substance lenalidomide as working in several ways, including through cytokine modulation, induction of T-cell proliferation, anti-proliferation of multiple myeloma cells, and inhibition of angiogenesis.[3] It is a derivative of thalidomide.[2]
Lenalidomide Krka, a medicine containing lenalidomide, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 10 December 2020. It is a generic of Revlimid, which has been authorised in the EU since 14 June 2007.[3]
Lenalidomide works as an immunomodulating agent through multiple mechanisms. These include modulation of cytokines, induction of T-cell proliferation, direct anti-proliferative effects on multiple myeloma cells, and inhibition of angiogenesis, which is the formation of new blood vessels that tumours need to grow.[3]
Lenalidomide is available as hard capsules in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg.[3] In the registered clinical trial, lenalidomide is listed as an oral drug.[1]
One trial is registered for lenalidomide hydrochloride hydrate in the provided data. The trial NCT04623541 is a Phase 1 interventional study investigating epcoritamab in subjects with relapsed/refractory chronic lymphocytic leukemia and Richter's syndrome, with lenalidomide included as a combination therapy arm.[1]
The trial enrolled 203 participants with relapsed/refractory chronic lymphocytic leukemia or Richter's syndrome.[1] The study includes both monotherapy cohorts and combination therapy cohorts with venetoclax, lenalidomide or R-CHOP.[1]
The primary outcomes include the incidence of dose-limiting toxicities, adverse events and serious adverse events, as well as objective response rate assessed by an independent review committee in the expansion cohorts. For the lenalidomide combination arm in Richter's syndrome, the objective response rate is assessed by the independent review committee.[1]
The trial is authorised and is an interventional study.[1]
The EMA catalogue describes a database study of lenalidomide in Germany that was required as part of a risk management plan due to the teratogenic potential of the drug. Teratogenic potential means the medicine can cause harm to a developing fetus.[2] The study monitored off-label use of lenalidomide based on claims data from around 14 million enrollees.[2]
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