SGN-30

Generic Name: SGN-30

Drug Type: Biotech

Overview

SGN-30 is an engineered monoclonal antibody (mAb) that reacts with significant affinity to the CD30 antigen, which is highly expressed on a variety of hematologic malignancies as compared to on normal cells. SGN-30 has been shown to induce direct anti-cancer activity towards tumor cells expressing CD30 and is undergoing phase II trials for cancer therapy. SGN-30 has demonstrated objective antitumor responses as a single agent in phase II clinical trials. We are collaborating with the National Cancer Institute (NCI) on three clinical trials of SGN-30 in combination with chemotherapy for the treatment of relapsed Hodgkin lymphoma, front-line ALCL and pediatric ALCL. SGN-30 received orphan drug designation from the FDA in July 2003 for Hodgkin lymphoma and in February 2004 for T-cell lymphomas.

Indication

Investigated for use/treatment in autoimmune diseases, cancer/tumors (unspecified), lymphoma (non-hodgkin's), and lymphoma (unspecified).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma	2006/08/17	NCT00365274	Phase 2	Terminated	National Cancer Institute (NCI)
Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma	2004/12/10	NCT00099255	Phase 2	Completed	Seagen Inc.
Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma	2004/03/16	NCT00079755	Phase 2	Completed	Seagen Inc.
A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies	2003/01/15	NCT00051597	Phase 1	Completed	Seagen Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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