FDA Gives Speedy Approval to Brentuximab for Peripheral T-Cell Lymphoma

The FDA announced Friday that it expanded the approved use of brentuximab vedotin (Adcetris) in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL), using a new review process designed to increase efficiency.

It is also the first FDA approval for treatment of newly diagnosed PTCL. PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from T-cells, which spread quickly and are hard to treat. T-cell lymphomas account for between 10% and 15% of all non-Hodgkin lymphomas, according to the Leukemia and Lymphoma Society.

The program under which the drug was approved, Real-Time Oncology Review (RTOR), allows the FDA to review much of the data after the clinical trial results become available and before the information is formally submitted to the FDA. The pilot focuses on early submission of data that are most relevant to assessing the safety and efficacy of a product.

The approval of brentuximab for PTCL is the fourth time the RTOR has been used, according to an FDA spokesperson.

“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely and thorough review,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, in a statement.

Brentuximab is an anti-CD30 monoclonal antibody. Earlier this month, an analysis found that it was cost-effective when combined with chemotherapy as front-line treatment for stage III or IV classical Hodgkin lymphoma.

The new approval was based on a clinical trial of 452 patients with certain PTCLs who received either brentuximab plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment. Progression-free survival was significantly longer (hazard ratio, 0.71; P = .01) in the brentuximab arm (median = 48 months vs 21 months with CHOP). Overall survival and overall response rates were also significantly better in the brentuximab arm.

The drug, sold by Seattle Genetics, had also received priority review and breakthrough therapy designation.

“By participating in the FDA’s Real-Time Oncology Review process and working closely with the FDA, we are now able to make the Adcetris regimen available to previously untreated patients with CD30-expressing PTCL in an unprecedented less than two weeks after submission of our supplemental BLA,” said Clay Siegall, PhD, the firm’s president and chief executive officer of Seattle Genetics, in a statement.

The most common side effects of brentuximab plus chemotherapy included peripheral neuropathy, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever, and anemia.