Hoy 29 de junio, la EMA ha emitido informe favorable de Kymriah y Yescarta por medio del mecanismo PRIME
Kymriah and Yescarta are also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive positive opinions from the Committee for Medicinal Products for Human Use (CHMP). The voluntary scheme provides early and enhanced scientific and regulatory support to medicines that have the potential to address, to a significant extent, patients’ unmet medical needs. Kymriah was granted eligibility to PRIME on 23 June 2016, for the treatment of acute lymphoblastic leukaemia (ALL). Yescarta was granted eligibility to PRIME on 26 May 2016 for the treatment of diffuse large B-cell lymphoma (DLBCL).
Fija la EMA la obligacion de un registro para seguir los pacientes:
Another important risk management measure for Kymriah and Yescarta is the utilisation of a patient registry to monitor the long-term safety and efficacy of these therapies, as a condition for the marketing authorisation. The application of registries to support the benefit-risk evaluation of CAR-T cell products and their post-authorisation follow-up was discussed in a specific workshop in early 2018, as part of EMA’s initiative on patient registries.
Además ha publicado Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry para pública consulta.
Es de suponer que en breve se publiquen sus correspondientes EPAR y posteriormente se negocie con los provisores de salud los precios a los que van a estar a su disposición estas terapias en la EU.
Le ruego evalúe la presente entrada asignando un valor de 1 a 5, de peor a mejor valorada, usando la opción de comentarios.
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