Está usted abandonando el sitio web de Lilly
La liga en la que hizo clic lo llevará a un sitio administrado por un tercero, quien es el único responsable de su contenido. ELI LILLY Y COMPAÑÍA DE MÉXICO S.A. DE C.V. no controla, influye o respalda este sitio, y las opiniones, reclamos o comentarios expresados en este sitio no son responsabilidad de ELI LILLY Y COMPAÑÍA DE MÉXICO S.A. DE C.V. y tampoco la política de privacidad de los sitios web de terceros. Le recomendamos que lea la política de privacidad de cada sitio web que visite. Haga clic en "Continuar" para proceder o "Regresar" para mantenerse en LillyMedical.com/mx
Haga una pregunta para buscar información del producto y recursos médicos de Lilly. Para activar la búsqueda escriba 3 términos.
Por favor no use este campo para reportar eventos adverso o quejas de productos.
Para consultar la información para prescribir completa de Cyramza® (Ramucirumab) de clic en el siguiente enlace:
Información para prescribir
La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.
Ramucirumab: EGFR Testing Methods in the RELAY Study
All patients were assessed for EGFR mutation status prior to study enrollment.
The information contained in this letter may notcompletely match the current local labeling for RAMUCIRUMAB.Please see local labeling approved in your country.
The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1
Local EGFR testing results were used for enrollment into the study; pre-planned central testing was conducted during the study using the therascreen® EGFR tissue assay on submitted archival tissue samples to corroborate activating mutation status. Central testing did not inform patient eligibility or study enrollment.2
Among the 316 patients (70% of the ITT population) with results obtained from the central therascreen® testing, 305 patients (96%) had an EGFR activating mutation detected, corroborating the local EGFR testing results used for enrollment. It is expected that the lack of a positive EGFR central test result in the 11 patients is likely due to tissue heterogeneity and the different tissue sections used for central versus local testing.2
Summarized by local testing method, activating EGFR mutations were detected centrally in
95% of tested patients who had been tested locally with a therascreen®/cobas® test, and
97% of tested patients who had been tested locally with an Other test.2
The similar EGFR activating mutation positivity rates found by central testing between the 2 local testing method subgroups, indicates that the difference in HRs observed between patients tested locally with therascreen®/cobas® vs. Other tests was not due to false positives from local assay variability. Additionally, when the 11 patients were removed for whom an EGFR activating mutation could not be detected in the samples submitted and tested centrally, the HR was essentially the same as that within the full set of centrally tested patients (HR=0.623 for patients with central tissue test [n=316]; HR=0.610 for patients with positive central tissue test [n=305]).2
1Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Talk presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
HR = hazard ratio
ITT = intent-to-treat
NSCLC = non-small cell lung cancer
PS = performance status
Fecha de la última revisión:2019 M07 26
Contáctenos para saber más de la información Médica de Lilly