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FDA Approves Breakthrough Treatment for Rare Lung Cancer Patients

The United States Food and Drug Administration (FDA) has approved alectinib, marketed as Alecensa to help treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has a gene mutation called ALK-positive.

Alectinib is a type of medicine used to treat a specific kind of lung cancer called non-small cell lung cancer (NSCLC). It works by blocking a protein called ALK (anaplastic lymphoma kinase), which is found in some cancer cells. By blocking this protein, alectinib helps stop the growth and spread of cancer cells in the body. 

It's often given to people whose cancer has spread or whose cancer hasn't responded to other treatments. The approval is for using alectinib after surgery to remove the tumour in patients with ALK-positive NSCLC. Patients need to have a test that shows they have this gene mutation before starting treatment with alectinib.

The approval was based on a study that included patients with ALK-positive NSCLC who had surgery to remove the tumor. Some patients took alectinib, while others took chemotherapy. The study found that patients who took alectinib had a longer time without the cancer coming back compared to those who took chemotherapy.

The most common side effects of alectinib include liver problems, constipation, muscle pain, tiredness, skin rash, and coughing.

Doctors recommend taking alectinib as a pill, 600 mg twice a day with food, for two years or until the cancer comes back or if the side effects are too severe.

The FDA worked with other countries to review this medicine as part of a program called Project Orbis. This programme helps speed up the review process for cancer drugs. The FDA also used a special program called Real-Time Oncology Review (RTOR) to quickly review the data before the entire application was submitted.

This medicine was given priority review and orphan drug designation, which means it was reviewed faster because it treats a rare disease.


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