Subscribe

Keytruda Indicated for BCG-Unresponsive High-Risk, Non–Muscle Invasive Bladder Cancer

February 2020 Vol 13, Special Issue: Payers' Perspectives in Oncology - Drug Updates, FDA Approvals

On January 8, 2020, the FDA accelerated the approval of a new indi­cation for pembrolizumab (Keytruda; Merck & Co) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer and carcinoma in situ, with or without papillary tumors, in patients who are ineligible for or who have elected not to undergo cystectomy. Pembrolizumab has been previously approved for many indications.

The approval was based on efficacy results from the KEYNOTE-057 clinical trial, a multicenter, single-arm study involving 148 patients with high-risk non–muscle invasive bladder cancer, of whom 96 had BCG-­unresponsive carcinoma in situ with or without papillary tumors. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity, persistent or recurrent high-risk disease, or progressive disease, or up to 24 months of therapy without disease progression.

The major efficacy outcomes were complete response, urine cytology, computed tomography urography, and duration of response. The complete response rate in the 96 patients with high-risk BCG-unresponsive disease with carcinoma in situ was 41% (95% confidence interval, 31-51), and the median response duration was 16.2 months. Overall, 46% of responding patients had a complete response lasting ≥12 months.

The most common (≥10%) adverse reactions with pembrolizumab in this study were fatigue, diarrhea, rash, pruritis, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.

Related Items
Xalkori Approved for Anaplastic Large-Cell Lymphoma and ALK Mutation in Young Patients
February 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology published on February 24, 2021 in FDA Approvals
Tagrisso Approved as Adjuvant Therapy for NSCLC with EGFR Mutations
February 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology published on February 24, 2021 in FDA Approvals, Lung Cancer
Xpovio Approved for Patients with Relapsed or Refractory Multiple Myeloma
February 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology published on February 24, 2021 in FDA Approvals, Multiple Myeloma
FDA Approves Tepmetko for Metastatic NSCLC and MET Exon 14 Skipping Alterations
February 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology published on February 23, 2021 in FDA Approvals
Orgovyx First FDA-Approved Oral Hormone Therapy for Advanced Prostate Cancer
February 2021 Vol 14, Special Issue: Payers' Perspectives in Oncology published on February 23, 2021 in FDA Approvals
Last modified: August 12, 2020
Copyright © Engage Healthcare Communications, LLC. All rights reserved.