The recent first global approval of durvalumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1] based on the development milestones tracked in AdisInsight.[2]

In May, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, received its first global approval in the US for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.[3]

Durvalumab is an intravenous fully human monoclonal antibody that blocks programmed cell death (PD) ligand-1 (PD-L1) and prevents it binding to PD-1 and DC-8 receptors. PD-L1 is up-regulated by a number of different tumours. Overexpression is related to poor prognosis; blocking PD-L1 results in increased recognition and killing of tumour cells by T-cells.

Durvalumab was granted Breakthrough Therapy designation, and the accelerated approval via priority review means that the continued approval of the drug is on condition that AstraZeneca perform additional trials to confirm the clinical benefit of the agent. [3]

The FDA also granted approval of a companion diagnostic kit to be used for identification of PD-L1 status in patients with bladder cancer. [3][4]

According to the American Cancer Society approximately 79,030 new cases of bladder cancer are expected in 2017, with just over 20% resulting in death. This form of cancer is more common in elderly (average age at diagnosis is 73 years) males (about 3-4 times greater than in women).[5]

Durvalumab is an agent discovered as part of the immune-oncology approach to finding successful treatments for cancer by stimulating the patient’s own immune system, rather than inflicting debilitating iatrogenic immunosuppression as seen with other anti-tumour agents.[6]

Imfinzi is the cornerstone of our extensive Immuno-Oncology programme, in development across many tumour types, as monotherapy and in combination,” said Pascal Soriot, Chief Executive Officer of AstraZeneca.  “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.”[6]

Nicholas J. Vogelzang, MD, FACP, FASCO, Clinical Professor at the University of Nevada School of Medicine; SWOG GU Vice Chair; US Oncology Research GU Chair; Comprehensive Cancer Centers of Nevada, highlighted that, “Patients who have disease progression during or following chemotherapy are left with few other treatment options. 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.” [6]

Durvalumab is also under Phase III investigation alone or in combination with tremelimumab[7] in urothelial carcinoma, small and non-small cell lung cancer as well as head and neck squamous cell carcinoma. Phase I and II investigations include a variety of solid tumours and haematological malignancies.

Prescribing information warns to be observant for infection and immune-related adverse events such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, and diabetes melitus.[8]

For further information related to the first approval of durvalumab please visit Drugs[1] or to learn more about the overall development of durvalumab across all indications visit AdisInsight.[2]

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