Perjeta® (pertuzumab)

BL 125409

Perjeta® (pertuzumab)

BL 125409

U.S. License Holder:

Genentech

Date of License:

June-08-2012

Last Update:

July-31-2025

approved_indications FDA-Approved Indications

PERJETA (pertuzumab) is a HER2/neu receptor antagonist indicated for:

Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease;

Use in combination with trastuzumab and chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Accepted by FDA

HLX11: Shanghai Henlius Biotech / Organon (February-2025)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:22-cv-00145 (D. Del.)

U.S. Patent Nos.
7,625,558 (Compositions and Methods of Treating Tumors)

Plaintiffs
Trustees of The University of Pennsylvania

Defendants
Genentech, Inc.

Status
Summary Judgment of Invalidity of Claims 8, 13, 35, 55, 60, 68, 74, 79, 81, 84, and 86 of U.S. Patent No. 7,625,558; Stipulated Dismissal due to Settlement

BPCIA
N

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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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