Adcetris® (brentuximab vedotin)

BL 125388

Adcetris® (brentuximab vedotin)

BL 125388

U.S. License Holder:

Seattle Genetics

Date of License:

August-19-2011

Last Update:

September-15-2020

approved_indications FDA-Approved Indications

ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate indicated for treatment of adult patients with:

Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine;

Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell stransplantation (auto-HSCT) consolidation;

Classical Hodgkin lymphoma after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates;

Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone;

Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen;

Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:12-cv-01734 (W.D. Wash.)

U.S. Patent Nos.
5,635,483 (Tumor Inhibiting Tetrapeptide Bearing Modified Phenethyl Amides)

Plaintiffs
Seattle Genetics, Inc.

Defendants
Arizona State University; Arizona Technology Enterprises; The Arizona Board of Regents

Status
Dismissed

BPCIA
N

2:14-cv-00653 (D. Ariz.)

U.S. Patent Nos.
5,635,483 (Tumor Inhibiting Tetrapeptide Bearing Modified Phenethyl Amides)

Plaintiffs
The Arizona Board of Regents

Defendants
Seattle Genetics, Inc.

Federal Circuit Appeal(s)
15-1998

Status
Case Terminated

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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