The Brazilian National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria de Brasil or ANVISA) approved the call for a public meeting on the measure that will regulate the use of lenalidomide in the country. Sector representatives, social entities, and citizens can present contributions regarding the proposal, which will be published in the Official Journal of the Union (Diario Oficial de la Unión) in coming days.

Lenalidomide is a molecule that has been indicated for the treatment of patients with refractory multiple myeloma (MMRR) who have received at least one prior course of treatment. The formulation is indicated for the treatment of low- to medium-risk patients with recurrent infusion-dependent anemia resulting from myelodysplastic syndrome (MDS) associated with a cytogenetic anomaly.

The use of lenalidomide involves risks due to its similarity to thalidomide, a known teratogen used in the treatment of leprosy but which can cause serious congenital life-threatening malformations. For this reason, its future regulation must stipulate essential requirements regarding its distribution, particularly in cases involving pregnancy.

You can access the vote of the rapporteur of the process, Director Fernando Mendes here.

Regulation

The discussion at the regulatory agency began following a presentation by a company that was interested in registering a medication based on lenalidomide. The request was evaluated by the agency based on quality, efficacy, and safety criteria. Notwithstanding, ANVISA seeks to establish clear and specific oversight and monitoring guidelines prior to authorizing the distribution of the product.

ANVISA has held a meeting with representatives from the Brazilian Association of Thalidomide Syndrome Victims (Asociación Brasileña de Portadores del Síndrome de Talidomida) to report on the drafting of the proposal. A forum to discuss future surveillance measures was also held by the Health Surveillance Center of São Paulo (Centro de Vigilancia Sanitaria de San Pablo), the unit responsible for oversight in the state where the company seeking the registration is located.

Lenalidomide in the world

In 2013, the drug was authorized to be sold on the market in the United States, the 27 member countries of the European Union, and 46 other nations, to be used for one or more specified indications. Its distribution is carried out according to special national and regional level programs and risk minimization plans, primarily focusing on preventing fetal exposure during pregnancy.