The United States Food and Drug Administration (FDA) has granted approval for the usage of Imfinzi to diagnose non-small cell lung cancer patients. This is apparently the first approval by the FDA for the treatment of stage III inoperable NSCLC that has been introduced in order to minimize the risk associated with cancer progression after the failure of chemoradiation treatment.
As per reliable sources, the approval is based on positive results obtained from the Phase III PACIFIC clinical trial. Imfinzi showed 48% reduction in the risk associated with the progression of cancer in all patients. For the approval of Imfinzi, FDA randomly treated 713 patients, whose cancer did not progress post radiation and chemotherapy treatment. As per the results obtained from trial, the median progression-free survival for patients who were treated with Imfinzi was 16.8 months, which was more as compared to patients taking a placebo treatment.
Post the approval for the immunotherapy drug, the Deutsche Bank analyst Richard Parkes stated that the official consent for the drug has been received a month earlier than expected. Over the coming four years, AstraZeneca is poised to add over USD 4 billion of profitable lung cancer sales, he says.
According to reports, lung cancer is one of the leading causes of cancer deaths across the United States. The National Cancer Institute claims that out of 222,500 newly diagnosed patients with lung cancer, 155,870 lost their lives in 2017. Stage III NSCLC apparently indicates that the cancer tumors have spread to other body parts, especially surrounding the lungs. Imfinzi however, cite sources, blocks PD-1/PD-L1 pathway interactions and allows the body’s immune system to attack cancer cells effectively. In 2017, Imfinzi also received approval for treating patients with metastatic bladder cancer.
For the record, post the treatment with Imfinzi, it is common for patients with stage III surgically non-removable NSCLC to witness side effects such inflammation in lungs, fatigue, cough, rash, difficulty in breathing, and infection in upper respiratory tract.