AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) granted accelerated approval toImfinzi(durvalumab).
The drug’s use is subject to change should further research show problems.
Imfinziis now indicted for the treatment of some patients with locally advanced bladder cancer. Imfinziis approved under the FDA’s accelerated approval pathway, based on tumor response rate and durability of response.
Pascal Soriot, CEO of AstraZeneca, said: “We are excited to offerImfinzias a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer.Imfinziis the cornerstone of our extensive Immuno-Oncology program, in development across many tumor types, as monotherapy and in combination. This first approval forImfinziis an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated.”
Imfinziis also under investigation in the Phase III treatment in another type of bladder cancer
Nicholas J. Vogelzang, MD,clinical professor at the University of Nevada School of Medicine, said: “The usual course of treatment for patients with advanced bladder cancer begins with a standard platinum-containing chemotherapy. Patients who have disease progression during or following chemotherapy are left with few other treatment options. The approval ofImfinzito treat this population of select patients signifies hope for those who are currently suffering, or may find themselves with limited options in the future.”
Urothelial bladder cancers arise from the epithelium of the bladder and are the ninth most common form of cancer worldwide. It is estimated that in 2016, about 430,000 people were diagnosed with bladder cancer around the world and 165,000 did not survive.
Metastatic bladder cancer remains an area of unmet medical. Among patients treated with standard-of-care chemotherapy, the five-year survival rate is below 15 percent.
AstraZeneca has 1,500 employees, but no research facilities in Delaware.