FDA Calls It! Seattle Genetics' Adcetris is a Breakthrough for Lymphoma

November 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BOTHELL, Wash. – Seattle Genetics ’ Adcetris could see expanded use soon following the U.S. Food and Drug Administration granting the drug Breakthrough Therapy Designation for the expanded treatment of lymphoma patients.

The FDA’s designation will provide a pathway for Adcetris to be used for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease, Seattle Genetics said this morning. The Breakthrough Therapy Designation, based on clinical evidence, is intended to expedite the review of promising drug treatments for serious medical issues. The company said it plans to submit its Biologics License Application to the FDA in the first half of 2017.

“The decision by the FDA to grant Adcetris Breakthrough Therapy Designation further reinforces our belief that Adcetris represents a meaningful advance in the treatment of CD30-expressing CTCL,” Clay Siegall, president and chief executive officer of Seattle Genetics, said in a statement. “The Breakthrough Therapy Designation supports our goal to expedite the review and approval process to make ADCETRIS available to patients in this setting who may benefit.”

Adcetris is an antibody-drug conjugate directed to CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL. Adcetris is currently not approved for the treatment of CTCL. However, the drug has been approved for classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation, for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression, and accelerated approval in patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

In August, Seattle Genetics, which is developing Adcetris with Japan-based Takeda, announced that its Phase III Adcetris trial of patients with cutaneous T-cell lymphoma (CTCL), met its primary endpoint, which showed highly statistically significant improvement in the rate of objective response that lasted at least four months. Additional trial data will be presented at the upcoming American Society of Hematology (ASH) annual meeting next month in San Diego.

Adcetris received orphan drug designation from the FDA for the treatment of MF, which is the most common type of CTCL. Adcetris also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF. The drug is being evaluated in more than 70 ongoing clinical trials. In 2015, Adcetris brought in $226 million for Seattle Genetics.

Despite the good news for Adcetris, shares of Seattle Genetics are down more than 4 percent this morning, hitting a low of $64.80, down from the opening price of $69.50.