En el mes de abril en EEUU,
por la FDA, se aprobaron varios medicamentos contra el cáncer, la mayoría ya
estaban comercializados para otras indicaciones y cinco que son nuevos.
Encorafenib (Braftovi, Array BioPharma/ Pfizer; FDA, EMA,
España) y cetuximab (Erbitux, Merk KGaA; FDA, EMA, España UH); Ibrutinib (Imbruvica,
Pharmacyclics LLC una AbbVie company; FDA, EMA, España) y rituximab (Rituxan,
Genentech; FDA, EMA, España); Luspatercept-aamt (Reblozyl, Celgene Corporation;
FDA, EMA huerfano); Mitomicina
(Jelmyto, UroGen Pharma; FDA); Niraparib (Zejula, GlaxoSmithKline; FDA, EMA, España DH);
Pembrolizumab (Keytruda, Merck; FDA, EMA, España UH); Pemigatinib (Pemazyre,
Incyte Corporation; FDA, EMA huerfano); Sacituzumab govitecan-hziy (Trodelvy, Immunomedics; FDA); Selumetinib (Koselugo,
AstraZeneca; FDA, EMA huerfano);
Tucatinib (Tukysa, Seattle Genetics; FDA)
Encorafenib (Braftovi, Array BioPharma/
Pfizer; FDA, EMA, España) y cetuximab (Erbitux, Merk KGaA; FDA, EMA,
España UH). Encorafenib es una pequeña molecula oral
inhibidor quinasa que se dirige a BRAF V600E, y cetuximab es un anticuerpo IgG1
monoclonal quimérico cuya diana es el receptor del factor de crecimiento
epidérmico (EGFR). Ya comercializados en otras indicaciones.
Código ATC: L01XE46 (encorafenib), L01XC06 (cetuximab).
Blog 14/02/2020
*FDA 8/04/2020,
ha aprobado la combinación de encorafenib y cetuximab como tratamiento de
pacientes con cáncer colorrectal metastásico (mCRC) con una mutación BRAF
v600E, según lo detectado por una prueba aprobada por la FDA (Qiagen
therascreen BRAF V600E RGQ PCR kit), después de una terapia previa.
*FDA 18/12/2019, aceptó un
sNDA (supplemental NDA) para la combinación en la indicación indicada.
Ibrutinib (Imbruvica,
Pharmacyclics LLC una AbbVie company; FDA, EMA, España) y rituximab
(Rituxan, Genentech; FDA, EMA, España). Ibrutinib es una molécula pequeña que
actúa como un potente inhibidor de la tirosina quinasa de Bruton (BTK) y
rituximab es un anticuerpo monoclonal que se dirige al antígeno CD20 expresado
en la superficie de los linfocitos B maduros y pre-B. Ya comercializados en
otras indicaciones.
Código ATC: L01XE27 (Ibrutinib), L01XC02 (rituximab). Blog 14/02/2020
*FDA 21/04/2020, amplió
la indicación de incluir su combinación con rituximab para el tratamiento
inicial de pacientes adultos con leucemia linfocítica crónica (CLL) o linfoma
linfocítico pequeño (SLL).
*FDA 8/11/2019, se presentó
un sNDA para la combinación de ibrutinib (Imbruvica) y rituximab (Rituxan) para
la misma indicación.
Luspatercept-aamt (Reblozyl, Celgene
Corporation; FDA) es una proteína de fusión recombinante.
FDA 3/04/2020
EMA medicamento huérfano
22/08/14
Código ATC: B03XA06
*FDA 3/04/2020,
aprobado para el tratamiento de la anemia que falla con
un agente estimulante de la eritropoyesis y que requiere 2 o más unidades de
glóbulos rojos (RBC) durante 8 semanas en pacientes adultos con síndromes
mielodisplásicos de riesgo muy bajo a intermedio con sideroblastos en anillo
(MDS-RS) o con
neoplasia mielodisplásico / mieloproliferativa con sideroblastos en anillo
y trombocitosis (MDS / MPN-RS-T).
Mitomicina (Jelmyto, UroGen Pharma; FDA)
antibiotico citostático inhibidor de la síntesis de ADN. Ya comercializado
en otras indicaciones.
FDA 15/04/2020
Código ATC: L01DC03. Blog 10/02/2020
*FDA 15/04/2020, aprobado
como gel para pacientes adultos con cáncer urotelial del tracto superior de
bajo grado (LG-UTUC).
*FDA 19/12/2018, otorgó una
Priority Review designation (designación de Revisión prioritaria) para la misma
indicación.
*FDA 31/10/2018, recibió una
Breakthrough Therapy Designation (designación de terapia innovadora) para la
misma indicación.
Niraparib (Zejula, Tesaro/ GlaxoSmithKline;
FDA, EMA, España DH), es un inhibidor de los enzimas PARP (Poli (ADP-Ribosa)
Polimerasa), que inhibe potentemente PARP-1 y PARP-2, que juega un papel en la
reparación del ADN.
Ya comercializado en otras indicaciones.
Código ATC: L01XX54.
*FDA 29/04/2020, aprobado
para el tratamiento de mantenimiento de pacientes adultos con cáncer epitelial
avanzado de ovario, de trompa de Falopio o cáncer peritoneal primario que están
en respuesta completa o parcial a la quimioterapia de primera línea a base de
platino.
Nota:
páginas Web utilizadas
-Novel Drug Approvals for 2020
(https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020)
-Hematology/Oncology
(Cancer) Approvals & Safety Notifications 2020 (https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications)
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