Astellas Pharma and Seattle Genetics received an early present from the U.S. Food and Drug Administration (FDA) – accelerated approval for Padcev, a first-of-its-kind treatment for adult patients with metastatic urothelial bladder cancer.
Late Wednesday, the FDA granted the two companies approval for the drug. Specifically, the approval is for adult patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. Padcev (enfortumab vedotin-ejfv) was approved under the FDA’s Accelerated Approval Program based on tumor response rate. The FDA’s Accelerated Approval Program allows approval of a medicine based on a surrogate endpoint if the medicine fills an unmet medical need for a serious condition. A global, randomized Phase III confirmatory clinical trial (EV-301) is underway and is also intended to support global registrations, the companies said.
Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancers. Accelerated approval was granted after the companies released data from a pivotal Phase II trial in June that showed Padcev rapidly shrank tumors in most patients. Patients treated with Padcev in the EV-201 study demonstrated a 44% objective response rate, with the median duration of tumor response at 7.6 months. Complete responses were observed in 12% of patients. Median overall survival (OS) was 11.7 months and the median progression-free survival was 5.8 months. Most responses occurred within the first cycle of treatment, and were observed across all pre-specified patient subgroups irrespective of lines of therapy, response to prior PD-1/L1 inhibitor, or presence of liver metastases, the companies said at the time of the announcement.
Astellas and Seattle Genetics noted that about 80 percent of people with this kind of cancer do not respond to treatment with checkpoint inhibitors and are desperately in need of additional treatment options.
Approximately 80,000 people in the U.S. will be diagnosed with bladder cancer this year. Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options.
Roger Dansey, chief medical officer at Washington-based Seattle Genetics, said Padcev is the first antibody-drug conjugate approved for patients facing the aggressive cancer. The medication is the culmination of years of innovative work on this technology, he said.
“This approval underscores our commitment to develop novel medicines that address unmet patient needs, and we’re grateful to the patients and physicians whose participation led to this outcome,” Andrew Krivoshik, Oncology Therapeutic Area Head at Astellas, said in a statement.
Andrea Maddox-Smith, chief executive officer of the Bladder Cancer Advocacy Network, called the approval of Padcev welcome news. While there have been new medications for bladder cancer approved over the past several years, Maddox-Smith said, “most people living with advanced stages of this disease face a difficult journey with few treatment options.” One of those newly-approved drugs for bladder cancer is Janssen’s Balversa, which won FDA approval in April. Balversa, a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor, was approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy.
