Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

NEW INDICATIONS

Keytruda Now FDA Approved for Adjuvant Treatment of Renal-Cell Carcinoma

JHOP - December 2021 Vol 11, No 6 - FDA Oncology Update
Download PDF

On November 17, 2021, the FDA accelerated the approval of a new indication for pembrolizumab (Keytruda; Merck), for the adjuvant treatment of patients with renal-cell carcinoma (RCC) at intermediate-high or high risk for recurrence after nephrectomy or after nephrectomy and resection of metastatic lesions.

This approval was evaluated in the KEYNOTE-564 study, a multicenter, randomized, double-blind, placebo-controlled clinical trial of 994 patients with RCC at intermediate-high or high risk for recurrence, or for patients with no evidence of disease. The patients were randomized in a 1:1 ratio to pembrolizumab every 3 weeks or to placebo for up to 1 year, until disease recurrence or unacceptable adverse events.

The primary end point was investigator-assessed disease-free survival (DFS), defined as time to recurrence, metastasis, or death. The overall survival (OS) was a secondary end point. At a prespecified interim analysis, significant improvement in DFS was demonstrated, including 109 (22%) DFS events in the pembrolizumab arm and 151 (30%) DFS events in patients receiving placebo (hazard ratio, 0.68; 95% confidence interval, 0.53-0.87; P = .0010). The median DFS was not reached in either arm. At the time of the analysis, OS data were not mature, and 5% of deaths were reported in the overall population.

The most common (≥20%) adverse reactions to pembrolizumab in this study were musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism.

Related Items
Pluvicto FDA Approved for PSMA-Positive Metastatic Prostate Cancer
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Carvykti Second BCMA-Directed CAR T-Cell Therapy FDA Approved for Multiple Myeloma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Keytruda Monotherapy FDA Approved for Endometrial Carcinoma with a Biomarker
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Lynparza Receives FDA Approval for Adjuvant Treatment of High-Risk Early Breast Cancer with BRCA Mutation
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Opdivo plus Platinum-Based Chemotherapy FDA Approved as First Neoadjuvant Treatment in Early-Stage NSCLC
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Kimmtrak, a Bispecific CD3 T-Cell Engager, First FDA-Approved Drug for Unresectable or Metastatic Uveal Melanoma
JHOP - February 2022 Vol 12, No 1 published on March 1, 2022 in FDA Oncology Update
Orencia First Drug FDA Approved for the Prevention of Acute Graft-versus-Host Disease
JHOP - February 2022 Vol 12, No 1 published on March 1, 2022 in FDA Oncology Update
Keytruda Now Approved for the Adjuvant Treatment of Stage IIB/IIC Melanoma
JHOP - February 2022 Vol 12, No 1 published on March 1, 2022 in FDA Oncology Update
Rituximab plus Chemotherapy FDA Approved for Several Pediatric Hematologic Malignancies
JHOP - February 2022 Vol 12, No 1 published on March 1, 2022 in FDA Oncology Update
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.