Seattle Genetics Inc. (SGEN) said Thursday that a committee of the U.S. Food and Drug Administration will review two Biologics License Applications for its lymphoma drug Adcetris on July 14, 2011.
The FDA's Oncologic Drugs Advisory Committee will review the applications for orphan-drug Adcetris as a treatment for relapsed Hodgkin lymphoma, and for relapsed systemic anaplastic large cell lymphoma, or ALCL.
Adcetris (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, a defining marker of Hodgkin lymphoma and ALCL. The drug is being developed in collaboration with Millennium: The Takeda Oncology company, a part of Japan's Takeda Pharmaceutical Co. Ltd. (TKPHF.PK, TKPYY.PK).
The FDA's Oncologic Drugs Advisory Committee, or ODAC, is a body that studies data concerning the efficacy/safety of marketed and investigational cancer products and makes appropriate recommendations to the agency.
Seattle Genetics' two Biologics License Applications for Adcetris were accepted for filing by the FDA in May. The regulator has granted a six-month priority review of both applications, and has established an action date of August 30, 2011, under the Prescription Drug User Fee Act.
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma.
Last week, Seattle Genetics reported positive results from a Phase-I trial of Adcetris in Hodgkin lymphoma patients. Data from the trial revealed objective responses and complete remissions in those patients.
SGEN is trading at $19.00, down $0.34 or 1.76%, on a volume of 1.18 million shares on the Nasdaq.
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