Is alectinib FDA approved?

Is alectinib FDA approved?

On November 6, 2017, the Food and Drug Administration granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

What company makes alectinib?

Both trials were sponsored by Roche, the manufacturer of alectinib. In the ALEX trial, the median progression-free survival was 26 months for patients treated with alectinib, compared with 10 months for patients treated with crizotinib. The overall response rate was 79% for alectinib and 72% for crizotinib.

What is the cost of alectinib?

Alectinib costs $42.17 per 150 mg capsule. At the recommended dose of 600 mg twice daily, alectinib costs $337.36 per day and $9,446.08 per 28 days.

Can I stop taking alectinib?

If you experience side effects, your doctor may change your dose of ALECENSA. Your doctor may also temporarily stop or permanently stop treatment with ALECENSA to help manage side effects.

Is ALK-positive lung cancer curable?

Stage IV is the most advanced form; meaning the disease has spread to distant parts of your body, such as your bones or brain. Stage IV is very hard to cure, if not impossible, for ALK-positive lung cancer at this time.

How long can you live with ALK lung cancer?

Survival rates for ALK-positive lung cancer are slightly better than those for non-small cell lung cancer overall. The aforementioned 2018 study found that people with late-stage ALK-positive disease live for an average of nearly 7 years.

How long has alectinib been around?

In November 2017 the FDA approved alectinib for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer. This based on the phase 3 ALEX trial comparing it with crizotinib.