March 30, 2020

The U.S. FDA has approved a new indication for Imfinzi® (durvalumab), manufactured by AstraZeneca. The drug is now indicated as a first-line treatment for adult patients who have extensive-stage small cell lung cancer (ES-SCLC) when used in combination with standard of care (SoC) chemotherapy (etoposide plus either carboplatin or cisplatin).

There are two primary forms of lung cancer—small cell and non-small cell. Small cell lung cancer is less common, making up 10-15% of cases, but it is more aggressive. The disease also may have few or no symptoms until it has spread throughout the body. About two out of three cases are not diagnosed until the cancer has reached the extensive stage, in which it has spread to both sides of the chest or to the fluid surrounding the lungs.

In a clinical trial, Imfinzi plus SoC chemotherapy reduced patients’ risk of death by 27% with a median overall survival time of 13 months versus 10.3 months with SoC alone. It also produced an objective response rate of 68% versus 58% in patients who received only SoC chemotherapy.

Recommended dosing is 1500mg of Imfinzi administered with chemotherapy once every three weeks for four cycles, then once every four weeks as a single agent until disease progression or unacceptable toxicity occur. Imfinzi is given as an intravenous (IV) infusion over the course of one hour.

First FDA approved in 2017, the drug is also indicated to treat urothelial carcinoma and non-small cell lung cancer.

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