Tecentriq® (atezolizumab)

BL 761034

Tecentriq® (atezolizumab)

BL 761034

U.S. License Holder:

Genentech Inc.

Date of License:

May-18-2016

Last Update:

Apr-15-2024

approved_indications FDA-Approved Indications


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

Non-Small Cell Lung Cancer (NSCLC): As adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on greater than or equal to 1 percent of tumor cells, as determined by an FDA-approved test; For the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained greater than or equal to 50 percent of tumor cells [TC greater than or equal to 50 percent] or PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 10 percent of the tumor area [IC greater than or equal to 10 percent]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; 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; In combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; For the treatment of adult 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;

Small Cell Lung Cancer (SCLC): In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC);

Hepatocellular Carcinoma (HCC): In combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy;

Melanoma: In combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma;

Alveolar Soft Part Sarcoma (ASPS): For the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

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

Defendants
Genentech, Inc.

Status
Stipulated Dismissal

BPCIA
N

Methodology

Information contained in the Venable 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 BiologicsHQ database.

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