Subscribe

Subscribe Today!

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

I'd like to receive:

Vegzelma a New Biosimilar FDA Approved for the Treatment of 6 Types of Cancer

JHOP - October 2022 Vol 12, No 5 - FDA Oncology Update
NEW DRUGS

On September 28, 2022, the FDA approved bevacizumab-adcd (Vegzelma; Celltrion), a VEGF inhibitor and a biosimilar to bevacizumab (Avastin), for the treatment of metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small-cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal-cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Bevacizumab-adcd is not indicated for the adjuvant treatment of colon cancer.

Bevacizumab-adcd is the fourth biosimilar to bevacizumab to be approved by the FDA. The approval was based on the totality of evidence showing no clinically meaningful differences in efficacy, safety, or pharmacokinetics between bevacizumab-adcd and the reference drug, including the results of a double-blind, randomized phase 3 clinical trial of 689 patients with metastatic or recurrent nonsquamous NSCLC.

In that study, the patients received 15 mg/kg of bevacizumab-adcd intravenously every 3 weeks for up to 6 cycles in the induction phase, followed by every 3 weeks until disease progression in the maintenance phase. The main end point was objective response at 21 weeks. The results showed that bevacizumab-adcd was highly similar to its reference drug in efficacy, safety, and pharmacokinetics.

The most common (>10%) adverse events with bevacizumab-adcd are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

Related Items
Elahere, First FRα-Directed Antibody, FDA Approved for FRα-Positive, Platinum-Resistant Ovarian Cancer
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Rezlidhia New IDH1 Inhibitor FDA Approved for Relapsed or Refractory AML with IDH1 Mutation
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Tecvayli, First Bispecific BCMA-Directed CD3 T-Cell Engager, Received FDA Approval for Relapsed or Refractory Multiple Myeloma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Imjudo, a New CTLA-4 Inhibitor FDA Approved in Combination with Imfinzi for Unresectable Hepatocellular Carcinoma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Imjudo FDA Approved with Imfinzi and Chemotherapy for Metastatic Non–Small-Cell Lung Cancer
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Rylaze Received FDA Approval of a New Dosing Regimen
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Adcetris plus Chemotherapy Now FDA Approved for Pediatric Patients with Classical Hodgkin Lymphoma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Libtayo plus Platinum-Based Chemotherapy Now FDA Approved for NSCLC without Genomic Aberrations
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Lytgobi FDA Approved for Intrahepatic Cholangiocarcinoma with FGFR2 Fusion
JHOP - October 2022 Vol 12, No 5 published on October 24, 2022 in FDA Oncology Update
Pedmark First Drug Approved for Hearing Loss Prevention in Children with Solid Tumors
JHOP - October 2022 Vol 12, No 5 published on October 24, 2022 in FDA Oncology Update
Copyright © The Lynx Group, LLC. All rights reserved.