AstraZeneca and its global biologics research and development arm, MedImmune, said the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab).
Imfinzi is used to treat patients “with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery,” AstraZeneca said in a press release.
Imfinzi is also being investigated as a first-line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab as part of the Phase III DANUBE trial, AstraZeneca said.
“We are excited to offer Imfinzi as a breakthrough therapy for patients with locally advanced or metastatic bladder cancer,” AstraZeneca CEO Pascal Soriot said in the release. “Imfinzi is the cornerstone of our extensive immuno-oncology program, in development across many tumor types, as monotherapy and in combination. This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated.”
The usual course of treatment for patients with advanced bladder cancer begins with a standard platinum-containing chemotherapy, Nicholas Vogelzang, clinical professor at the University of Nevada School of Medicine, said in the release.
“Patients who have disease progression during or following chemotherapy are left with few other treatment options," Vogelzang said."The approval of Imfinzi to treat this population of select patients signifies hope for those who are currently suffering, or may find themselves with limited options in the future.”