Therapeutic Response

v::ALK status confers therapeutic sensitivity to Alectinib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Alecensa (alectinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to alectinib for the adjuvant treatment of adult patients, following tumor resection, with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive), as detected by an FDA-approved test.
Alecensa (alectinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to alectinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Alecensa (alectinib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized alectinib as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Alecensa (alectinib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized alectinib as a monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Alecensa (alectinib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized alectinib as a monotherapy for the adjuvant treatment following complete tumor resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence.