FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer - Seite 3

About lung cancer

According to the American Cancer Society, it is estimated that more than 238,000 Americans will be diagnosed with lung cancer in 2023, and NSCLC accounts for 80-85% of all lung cancers. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure. Approximately five percent of people with NSCLC are ALK positive. ALK-positive NSCLC is often found in younger people – usually 55 and under. Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.

About Alecensa (alectinib)

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. It can be used to help prevent lung cancer from coming back in patients after their tumor has been removed by surgery (adjuvant), or to treat patients when their lung cancer has spread to other parts of the body (metastatic).

A doctor will perform a test to make sure that Alecensa is right for their patient. It is not known if Alecensa is safe and effective in children.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

• Feeling tired
• Feeling less hungry than usual
• Yellowing of the skin or whites of the eyes
• Dark urine
• Itchy skin
• Nausea or vomiting
• Pain on the right side of stomach area
• Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.