On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pomalidomide Zentiva, intended for the treatment of multiple myeloma.

The applicant for this medicinal product is Zentiva, k.s.

Pomalidomide Zentiva will be available as 1, 2, 3 and 4 mg hard capsules. The active substance of Pomalidomide Zentiva is pomalidomide, an immunomodulator (ATC code: L04AX06). Pomalidomide works in different ways, including through cytokine modulation, induction of T-cell proliferation, inhibition of multiple myeloma cell proliferation and inhibition of angiogenesis.

Pomalidomide Zentiva is a generic of Imnovid, which has been authorised in the EU since 05 August 2013. Studies have demonstrated the satisfactory quality of Pomalidomide Zentiva, and its bioequivalence to the reference product Imnovid. A question and answer document on generic medicines can be found here.

The full indication is:

Pomalidomide Zentiva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Treatment with Pomalidomide Zentiva should be initiated and supervised by a physician experienced in the treatment of multiple myeloma.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.