FDA Approves Jideytro for Advanced ROS1-Positive Lung Cancer

The FDA has approved Jideytro (zidesamtinib), a medicine for adults with a type of lung cancer called non-small-cell lung cancer (NSCLC). This approval is for cancer that has spread within the chest or to other parts of the body. It is specifically for patients whose cancer has an abnormal gene called ROS1 and who have already taken a type of medicine called a ROS1 inhibitor.Jideytro works by targeting and blocking the abnormal ROS1 protein in cancer cells. This protein can cause cancer cells to grow and spread. Jideytro’s design allows it to reach cancer cells throughout the body, including ones that have spread to the brain. By blocking this target, the medicine helps slow down or stop the growth of the cancer.

Why Was It Approved?

The FDA approved Jideytro based on results from a clinical study called ARROS-1. The main study group included 117 adults with advanced ROS1-positive NSCLC who had previously received a ROS1 inhibitor. In this study, all patients took Jideytro to test how well it worked.

Over the course of the study, 44% of patients had their cancer tumors shrink. Among the patients who responded to treatment, 82% kept their response for longer than six months. About 69% kept their response for longer than 12 months. The medicine also helped shrink cancer that had spread to the brain. Among patients with measurable brain tumors, 48% saw their brain tumors shrink.

What Should You Know Before Taking This Medicine?

Jideytro comes as a tablet that you swallow whole. You can take it with or without food at the same time once every day. Do not split, chew, crush, or dissolve the tablets. Always tell your health care provider about all medicines, vitamins, and herbal supplements you take, because some can affect how Jideytro works.

The most common side effects include swelling in the body, numbness or tingling in your arms or legs, constipation, feeling tired, and shortness of breath.

This medicine can also cause serious health problems. It can affect your brain and nervous system, causing dizziness, memory loss, confusion, speech problems, anxiety, or mood changes. Do not drive or operate machinery until you understand how this medicine affects your mental alertness and coordination.

Other serious risks include heart rhythm problems, severe lung swelling, bone fractures, muscle pain or weakness, and inflammation of the pancreas (pancreatitis). Your health care provider will run blood and heart tests before and during treatment to check for these risks.Jideytro may cause fertility problems. Speak with your health care provider if this is a concern for you. It can also harm a fetus. Females who can get pregnant should use effective birth control during treatment and for six months after the last dose. Males with partners who can get pregnant should use effective birth control during treatment and for three months after the last dose. Do not breastfeed during treatment and for a week after your last dose.