The FDA granted priority review to rucaparib (Rubraca) for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer (mCRPC), according to Clovis Oncology, the drug’s manufacturer.1 The agency set a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. The application is based on findings from the ongoing, international, multicenter, open-label phase II TRITON2 trial that enrolled male patients with mCRPC associated with 1 of 13 homologous recombination repair (HRR) gene alterations. Patients were treated with rucaparib at 600 mg twice daily until radiographic progression or treatment discontinuation. The primary endpoints of the trial include confirmed ORR per RECIST/Prostate Cancer Clinical Trials Working Group 3 criteria in patients with measurable disease at baseline and PSA response in patients with no measurable disease at baseline. Patients treated with the PARP inhibitor induced a 43.9% confirmed objective response rate (ORR; 95% CI, 24.4%-65.1%) by investigator assessment in 57 RECIST–evaluable patients with BRCA1/2-mutant mCRPC. Among those with BRCA1/2 alterations, 51.1% had a confirmed PSA response to rucaparib. All 11 investigator-assessed radiographic responses in the patients with BRCA-mutated tumors were partial responses (PRs); 9 patients (36.0%) had stable disease. The median duration of response had not been reached. The most common any-grade treatment-emergent adverse events occurring in >20% of patients were asthenia/fatigue (55.3%), nausea (49.5%), anemia/decreased hemoglobin (37.9%), decreased appetite (27.9%), transient increased aspartate transaminase/alanine aminotransferase (24.7%), constipation (24.7%), vomiting (22.1%), and diarrhea (21.1%).

Subscribirse al Directorio
Escribir un Artículo

Últimas Noticias

El diagnóstico genético neonatal mejor...

Un estudio con datos de los últimos 35 años, ind...

Más de 1.500 cambios epigenéticos en e...

Un equipo de investigadores de la Universidad Juli...

Tuneable reverse photochromes in the sol...

A new technique allows the design of solid materia...

Destacadas

Eosinófilos. ¿Qué significa tener val...

by Labo'Life

En nuestro post hablamos sobre este interesante tipo de célula del si...

Un estudio de INCLIVA muestra el efecto ...

by INCLIVA

Han desarrollado un estudio para evaluar la correlación entre el teji...

Diapositiva de Fotos