Subscribe

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive:

NEW INDICATIONS

Keytruda Received FDA Approval for First-Line Treatment of HER2-Positive Advanced Gastric Cancer

JHOP - June 2021 Vol 11, No 3 - FDA Oncology Update
Download PDF

On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This approval was based on findings from the prespecified interim analysis of 264 patients with advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the ongoing KEYNOTE-811 clinical trial who had not received systemic therapy for metastatic disease. This multicenter, randomized, double-blind, placebo-controlled study randomized the 264 patients in a 1:1 ratio to pembrolizumab 200 mg or to placebo every 3 weeks, in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The main efficacy measure for this analysis was the overall response rate (ORR). The ORR was 74% (95% confidence interval [CI], 66-82) in the pembrolizumab arm versus 52% (95% CI, 43-61) in the placebo arm, a significant difference (one-sided P value <.0001). The median duration of response was 10.6 months in the pembrolizumab arm versus 9.5 months in the placebo arm.

The adverse reactions reported in this study for pembrolizumab were consistent with the drug’s known safety profile.

The recommended pembrolizumab dose for these indications is 200 mg every 3 weeks or 400 mg every 6 weeks.

Related Items
Omisirge FDA Approved for Patients with Hematologic Malignancies to Reduce Time to Neutrophil Recovery and Infection
Online First published on May 12, 2023 in FDA Oncology Update
Padcev plus Keytruda Granted Accelerated FDA Approval for Locally Advanced or Metastatic Urothelial Carcinoma
Online First published on April 24, 2023 in FDA Oncology Update
FDA Approved Zynyz for Metastatic or Recurrent Locally Advanced Merkel-Cell Carcinoma
JHOP - April 2023 Vol 13, No 2 published on March 31, 2023 in FDA Oncology Update
FDA Approved Tafinlar plus Mekinist for Pediatric Patients with BRAF V600E Mutation–Positive Low-Grade Glioma
JHOP - April 2023 Vol 13, No 2 published on March 31, 2023 in FDA Oncology Update
FDA Granted Jemperli Regular Approval for dMMR Endometrial Cancer
JHOP - April 2023 Vol 13, No 2 published on March 31, 2023 in FDA Oncology Update
FDA Expanded Eligibility for Verzenio plus Endocrine Therapy in Patients with Early Breast Cancer
JHOP - April 2023 Vol 13, No 2 published on March 31, 2023 in FDA Oncology Update
Trodelvy Now FDA Approved for HR-Positive, HER2-Negative Breast Cancer
JHOP - April 2023 Vol 13, No 2 published on March 31, 2023 in FDA Oncology Update
Orserdu FDA Approved for ER-Positive Advanced or Metastatic Breast Cancer with ESR1 Mutation
JHOP - February 2023 Vol 13, No 1 published on February 27, 2023 in FDA Oncology Update
Jaypirca, a New BTK Inhibitor, Received FDA Accelerated Approval for Relapsed or Refractory Mantle-Cell Lymphoma
JHOP - February 2023 Vol 13, No 1 published on February 27, 2023 in FDA Oncology Update
FDA Approved Lunsumio for Relapsed or Refractory Follicular Lymphoma
JHOP - February 2023 Vol 13, No 1 published on February 27, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.