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Estados Unidos aprobó el primer tratamiento génico contra el cáncer en el mundo


Raquel Segovia

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El Kymriah es destinado a niños y adultos jóvenes menores de 25 años que han resistido a otras terapias contra la leucemia linfoide aguda, el cáncer de sangre pediátrico más frecuente en el país. El costo de un tratamiento es de 475.000 dólares

El Kymriah es destinado a niños y adultos jóvenes menores de 25 años que han resistido a otras terapias contra un tipo de leucemia o que han tenido una recaída

El Kymriah es destinado a niños y adultos jóvenes menores de 25 años que han resistido a otras terapias contra un tipo de leucemia o que han tenido una recaída

La agencia federal de alimentos y medicamentos de Estados Unidos, la FDA (por sus siglas en inglés), aprobó el miércoles la comercialización de la primera terapia génica en el mundo, que consiste en modificar genéticamente el sistema inmunológico de un enfermo para combatir una agresiva forma de leucemia.

Se trata del medicamento de nombre comercial Kymriah, de la empresa farmacéutica suiza Novartis, según informó la FDA en un comunicado.

Cada dosis del medicamento contiene células del sistema inmune del paciente que han sido modificadas genéticamente usando un virus para que puedan reconocer y eliminar la fuente del cáncer.

La FDA anunció el miércoles que aprobó este medicamento para niños y adultos jóvenes que sufren leucemia linfoide aguda, el tipo de cáncer más común en la infancia en Estados Unidos, donde cada año son diagnosticados unos 3.100 pacientes de 20 años o menos.

 

Este tratamiento supone una segunda oportunidad para los pacientes a los que les han fallado las terapias de primera línea, algo que ocurre a hasta un quinto de los enfermos, según la FDA.

"Estamos entrando en una nueva frontera en la innovación médica con la capacidad de reprogramar las propias células del paciente para que ataquen a un cáncer mortífero", indicó en un comunicado el presidente de la FDA, Scott Gottlieb.

"Nunca hemos visto nada como esto antes y creo que esta terapia quizás se convierta en el nuevo estándar para estos pacientes", apuntó el doctor Stephan Grupp, director de inmunoterapia del cáncer en el Children's Hospital de Philadelphia.

El medicamento tiene un precio de 475.000 dólares, pero los pacientes que no respondan a él en un mes no tendrán que pagarlo, según explicó Novartis en un comunicado.

La seguridad y eficacia de Kymriah han sido demostradas por una prueba clínica a 63 pacientes pediátricos y adultos jóvenes que no habían respondido a los otros tratamientos o habían recaído.

La tasa de remisión alcanzó el 83% en los tres primeros meses del tratamiento que consiste en una sola dosis de células inmunes modificadas, precisó la FDA.

Alrededor de 5.000 personas fueron diagnosticadas con leucemia linfoide aguda en 2014 en los EEUU, más de la mitad niños y adolescentes, según los Centros para el Control y Prevención de Enfermedades (CDC) del país.

Según Novartis, 600 enfermos serían elegibles cada año para este tratamiento.

La mayoría de los pacientes con esta enfermedad se recuperan con tratamientos como la radiación, la quimioterapia y las células madre, pero si el cáncer vuelve el diagnóstico suele ser malo.

Por otra parte, el Kymriah podría tener efectos secundarios severos, como infecciones graves, fiebres fuertes, hipotensión arterial, problemas renales y una disminución de oxígeno en la sangre.

Novartis y otros laboratorios trabajan de manera activa en el desarrollo de tratamientos similares para la mieloma múltiple, otra forma de leucemia y un tumor agresivo de cerebro.

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