Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: atezolizumab + bevacizumab
Trade Name: Tecentriq and Avastin
Date Designated: 01/08/2018
Orphan Designation: Treatment of hepatocellular carcinoma (HCC)
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
MS 451A
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: atezolizumab + bevacizumab
Trade Name: Tecentriq and Avastin
Marketing Approval Date: 05/29/2020
Approved Labeled Indication: TECENTRIQ, in combination with bevacizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Exclusivity End Date: 05/29/2027 
Exclusivity Protected Indication* :  TECENTRIQ for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
2 Generic Name: atezolizumab + bevacizumab
Trade Name: Tecentriq and Avastin
Marketing Approval Date: 05/29/2020
Approved Labeled Indication: AVASTIN, in combination with atezolizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Exclusivity End Date: 05/29/2027 
Exclusivity Protected Indication* :  AVASTIN for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-