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.
Alectinib Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved alectinib for reimbursement as a treatment option for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. This indication is specifically for patients whose tumors have been historically confirmed to be NSCLC with an ALK rearrangement identified by an approved and validated test method.
Alectinib Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved alectinib for reimbursement as a monotherapy treatment option for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This indication is specifically for patients whose tumors have been historically confirmed to be NSCLC with an ALK rearrangement identified by an approved and validated test method.
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.