PADCEV gains the approval of the U.S Food and Drug Administration for the treatment of metastatic and locally advanced urothelial cancer. Astellas Pharma Inc. and Seattle Genetics Inc. announced the approval of PADCEV (enfortumab vedotin-ejfv) by the U.S Food and Drug Administration for the treatment of advanced urothelial cancer patients.
PADCEV gains approval under the FDA’s Accelerated Approval Program which is based on the tumor response rate. It is a Nectin -4 directed antibody and tubulin inhibitor-based conjugate which results in the directed action; the drug only targets the cancerous cells.
PADCEV is marked effective for the treatment of both metastatic (abnormal proliferation) and locally advanced (surgically removable) urothelial cancer who have already received a platinum-chemo, PD-1/L1 inhibitors.
These are the standard treatments for bladder cancer. PD-1 is a programmed death receptor-1, PD-L1 is the programmed death-ligand 1, these inhibitors are the basic treatment for the patients with urothelial cancer. urothelial cancer is one of the most common cancers in the United States.
It is estimated that above 90% of urothelial cancers, start in the cells that adjoin the bladder with neighboring organs. PADCEV is the first and only FDA approved treatment for urothelial cancer patients with the progressed disease after immunotherapy and chemotherapy.
This study is published on the FDA’s official website; news release section. Click here to read it.
The director of the FDA’s Oncology Center of Excellence, Richard Pazdur, M.D. said that the antibody-drug conjugates are the vital tools for targeted cancer treatment. These conjugates help the monoclonal antibodies to target receptors of cancerous cells and also help in drug delivery to the cancerous cells. He said that PADCEV is the conjugate that targets the cell surface protein, Nectin-4 on bladder cancerous cells and a cell-killer, monomethyl auristatin E.
The Vice President of Astellas, Andrew Krivoshik M.D., Ph.D. said that PADCEV’s approval highlights their commitment to the development of new medicines that address the unmet medical needs and showed gratitude for the participation of the physicians and the patients which led to this outcome.
FDA approval was based on the outcomes of the clinical trials comprising 125 cancer patients, (including both metastatic and locally advanced bladder cancer) who were previously treated with standard treatments. The study outcomes give evidence that shows the efficacy of PADCEV.
The U.S. FDA advises health professionals to aware of the patients in reproductive age to use contraception during the treatment. Pregnant women or those who are breastfeeding should not take PADCEV as it may harm a newborn or a developing fetus.
PADCEV can cause hyperglycemia, peripheral neuropathy, ocular disorders, infusion site extravasations, skin reactions, embryo-fetal toxicity, and some other adverse reactions. So precautions must be taken by the patients.
An Accelerated Approval was granted to PADCEV, which makes the FDA approve the pharmaceutical products to bridge the unmet medical requirements for serious events. This is based on the outcomes that predict clinical benefits. Continued Approval is conditioned based on description and verification of clinical benefits in the confirmatory trials.
The FDA allowed this application Breakthrough Therapy designation and Priority Review, which will accelerate the production and review of therapeutic drugs for the treatment of serious conditions. The elementary clinical evidence predicts that the product may show substantial improvement over already available therapies.