Press Announcements > FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

Press Announcements > FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot





FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly. 

“The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products. “When the sponsor submits the completed application, the review team will...