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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: alectinib
Trade Name: Alecensa
Date Designated: 01/27/2015
Orphan Designation: Treatment of ALK-positive non-small cell lung cancer
Orphan Designation Status: Designated/Approved
Hoffmann-La Roche, Inc. (c/o Genentech, Inc.)
1 DNA Way, MS #355E
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: alectinib
Trade Name: Alecensa
Marketing Approval Date: 12/11/2015
Approved Labeled Indication: ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Exclusivity End Date: 12/11/2022 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib
2 Generic Name: alectinib
Trade Name: Alecensa
Marketing Approval Date: 11/06/2017
Approved Labeled Indication: ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Exclusivity End Date: 11/06/2024 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA-approved test, excluding patients who have progressed on or are intolerant to crizotinib.
3 Generic Name: alectinib
Trade Name: Alecensa
Marketing Approval Date: 04/18/2024
Approved Labeled Indication: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors greater than or equal to 4 cm or node positive), as detected by an FDA-approved test
Exclusivity End Date: 04/18/2031 
Exclusivity Protected Indication* :  adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors greater than or equal to 4 cm or node positive), as detected by an FDA-approved test
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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