Singapore: AstraZeneca and its global biologics research and development arm, MedImmune have received  approval for their bladder cancer drug IMfinzi from the US regulators. The UK-based firm believes that the drug will become a “cornerstone” in their immuno-oncology portfolio and could generate more than $6.5 billion in global sales. The company announced that US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab).

Imfinzi is indicated for the treatment of 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.

Imfinzi was approved six weeks ahead of its user fee goal date through the accelerated approval process. AstraZeneca will be required to complete ongoing clinical trials to confirm the effectiveness of the drug, which is the fifth PD1/PDL1-targeting checkpoint inhibitor to reach markets in the U.S. 

Bladder cancers is 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 need in particular; among patients treated with standard-of-care chemotherapy, the five-year survival rate is below 15%.

AstraZeneca’s CEO, Mr Pascal Soriot, said, ““We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer. Imfinzi is the cornerstone of our extensive Immuno-Oncology programme, in development across many tumour 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.”

Marketed as Imfinzi, the drug will treat advanced bladder cancer in patients whose disease has advanced despite chemotherapy. But the drug may not be limited to just the bladder cancer market. AstraZeneca is testing the medicine for lung, head, neck, liver and blood cancers. Imfinzi is involved in 19 different clinical trials, including 13 in combination with another therapy, AstraZeneca's vice president of U.S. Oncology, Michelle Werner, told The News Journal.

The accelerated FDA approval of Imfinzi, a human monoclonal antibody that blocks PD-L1, is based on data from Study 1108. This Phase I/II trial evaluated the safety and efficacy of Imfinzi in patients with locally-advanced or metastatic urothelial carcinoma of the bladder. Patients had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting.

The approval is a huge win for AstraZeneca as the company is trying to revive its sales lost due to  loss of patent protections for older, blockbuster medicines such as Crestor, a cholesterol medicine, and Nexium, a heartburn drug. The company has invested heavily in its immune-oncology portfolio and this approval might help the coampny reverse its five years of sales decline.