Expanded Approval for Imfinzi
February 16, 2018 – The U.S. FDA has expanded the approval for Imfinzi® (durvalumab), manufactured by AstraZeneca. Under the expanded approval, the drug is indicated to treat patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation. It is the first treatment approved for this population to reduce the risk of disease progression.
In 2017, an estimated 222,500 Americans were diagnosed with lung cancer, and the disease accounted for 155,870 American fatalities. NSCLC is the most common type of lung cancer, and in stage III, the cancer has spread to areas near the lungs, including the lymph nodes.
A programmed death-ligand 1 (PD-L1) blocking antibody, Imfinzi affects the PD-1/PD-L1 pathway and is believed to help the body’s immune system attack cancer cells. It was originally approved in 2017 to treat locally advanced or metastatic urothelial carcinoma.
Approval for treatment of stage III NSCLC was based on a clinical trial in which the progression free survival of patients who received Imfinzi was three times as long (16.8 months) as those who received a placebo (5.6 months). AstraZeneca has agreed to continue studying Imfinzi under the expanded approval to determine overall survival rates for patients with unresectable stage III NSCLC.
Imfinzi has a recommended dosing schedule of 10mg/kg via intravenous infusion over the course of one hour every two weeks. Treatment should continue until disease progression, unacceptable toxicity, or for a maximum of 12 months. Possible severe side effects include immune-mediated attacks on healthy cells or organs, such as the lungs, liver, colon, and kidneys.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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