Tecentriq® (atezolizumab)

BL 761034

Tecentriq® (atezolizumab)

BL 761034

U.S. License Holder:

Genentech Inc.

Date of License:

May-18-2016

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


TECENTRIQ (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in:

Urothelial Carcinoma: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 5 percent of the tumor area), as determined by an FDA-approved test, or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status, or have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy;

Non-Small Cell Lung Cancer (NSCLC) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment, of patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; for the treatment of patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Meyers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Genentech, Inc.

Status
Case Ongoing

BPCIA
N

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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