FDA Approves Osimertinib for Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer Following Chemoradiation Therapy

The FDA has approved a new treatment for some people with lung cancer. The treatment is a drug called osimertinib, also known as Tagrisso. It’s made by a company called AstraZeneca. This approval is for people with a specific type of lung cancer. It’s called non-small cell lung cancer (NSCLC) that has changes in a gene called EGFR.

The cancer must be locally advanced, which means it has spread but not to other parts of the body. It also must be unresectable, which means doctors can’t remove it with surgery. Before getting osimertinib, patients must have already had two other treatments. First, they need to have chemotherapy, which uses strong drugs to kill cancer cells. They also need to have radiation therapy, which uses high-energy beams to destroy cancer cells.

The FDA based its decision on results from a study called LAURA. This study looked at how well osimertinib worked compared to a placebo (a fake treatment). The results were very good. People who took osimertinib lived much longer without their cancer getting worse. Osimertinib is a type of drug called a tyrosine kinase inhibitor. It works by blocking signals that tell cancer cells to grow and divide. This can slow down or stop the growth of tumors. Like all drugs, osimertinib can have side effects. The most common ones include diarrhea, rash, and nail problems. Some people might have more serious side effects, so doctors will watch patients closely.

This approval is good news for people with this type of lung cancer. It gives them a new treatment option that could help them live longer without their cancer getting worse. It’s especially important because this type of cancer is hard to treat when surgery isn’t possible. Doctors are excited about this new treatment. They hope it will help many patients with this difficult type of lung cancer.