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Roche wins FDA OK for Alecensa in early lung cancer

The Food and Drug Administration has made a medicine from Roche the first specifically available for early treatment of lung tumors driven by a well-known cancer gene.

On Thursday, the agency cleared use of the drug, Alecensa, after surgical removal of a tumor in patients whose non-small cell lung cancer is positive for mutations in a gene called ALK. The approval makes Alecensa the first targeted treatment in that so-called adjuvant setting, during which patients typically receive chemotherapy.

The approval is the latest step in treatment for the most common form of lung cancer and one of the leading causes of cancer-related deaths. An estimated 125,000 people in the U.S. die each year from lung cancer, and 80% to 85% of lung tumors are of the “non-small cell” variety, according to the American Cancer Society.

Over the last decade, drugs that harness the immune system have become standard options for the disease. Some are available earlier in treatment, either before or after a tumor is surgically removed.

Several medicines targeting genetic drivers of certain lung tumors, like ALK and EGFR, have also emerged and become widely used. So have medicines for people whose cancers have so-called RET fusions or are what’s known as ROS1-positive. Drugs aimed at another lung cancer target, TROP2, are in advanced testing and one, from AstraZeneca and Daiichi Sankyo, could be approved by the end of the year.

Roche’s drug is for the estimated 5% of lung cancer patients with ALK mutations. Alecensa is already available for those with metastatic disease, as are Pfizer’s Xalkori and Takeda’s Alunbrig. But until Thursday, none had been available right after surgery and before a tumor spreads elsewhere. Cancers recur in about half of patients whose lung tumors are surgically removed, according to Roche.

Additionally, those with ALK mutations are typically diagnosed “at a younger age, often face recurrence and have a higher risk of developing brain metastases” than people with other types of non-small cell lung cancer, said Ken Culver, head of research and clinical affairs at the patient advocacy group ALK Positive, in a statement provided by Roche.

In testing, Alecensa reduced the risk of disease progression or death by 76% compared to chemotherapy in a study of 257 patients. Median disease-free survival, a measure of disease recurrence, was just over 41 months for people who received chemotherapy, but wasn’t reached in those who received Alecensa. Similar results were seen in the subgroup of patients with Stage 2 or 3A disease.

Liver damage, constipation, muscle pain, COVID-19 and fatigue were among the most common adverse events in patients who received treatment in the study.

The application was approved one month ahead of the FDA’s decision deadline as part of the “real-time oncology review” program, which allows the agency to begin evaluating an application before it is completed.