Subscribe

Subscribe Today!

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

I'd like to receive:

Adstiladrin, First Adenoviral Vector–Based Gene Therapy, FDA Approved for High-Risk Non–Muscle Invasive Bladder Cancer

JHOP - February 2023 Vol 13, No 1 - FDA Oncology Update

On December 16, 2022, the FDA approved nadofaragene firadenovec-vncg (Adstiladrin; Ferring Pharmaceuticals), a nonreplicating adenoviral vector–based gene therapy, for adults with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non–muscle invasive bladder cancer (NMIBC) and carcinoma in situ, with or without papillary tumors. The FDA granted this indication breakthrough therapy and orphan drug designations.

This approval was based on the results of Study CS-003, a multicenter, single-arm trial of 157 patients with high-risk NMIBC, including 98 patients with BCG-unresponsive carcinoma in situ who were evaluable for response. Patients received nadofaragene firadenovec 75 mL via intravesical instillation (3 × 1011 viral particles/mL [vp/mL]) once every 3 months for up to 12 months, until unacceptable adverse events or until recurrent high-grade NMIBC. Patients without high-grade disease recurrence continued to receive nadofaragene firadenovec every 3 months.

The major efficacy measures were a complete response (CR) at any time and the duration of response (DOR). Random bladder biopsies of 5 sites were done in patients with a CR at 12 months. The CR rate was 51% (95% confidence interval, 41%-61%) and the median DOR was 9.7 months (range, 3-≥52); 46% of the responding patients had a sustained CR for at least 1 year.

The most common (≥10%) adverse events, including laboratory abnormalities (>15%), were elevated glucose level, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition urgency, increased creatinine, hematuria, decreased phosphate, chills, dysuria, and pyrexia.

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.