Posted from: Tuesday, March 20, 2018 - 04:03 PM - Present

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.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Tuesday, June 19, 2018 - 01:31 AM.