Posted by Michael Wonder on 16 Nov 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
16 November 2018 - The U.S. FDA 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.
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 new approval was based on a clinical trial of 452 patients with certain PTCLs who received either Adcetris plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment. Progression-free survival (the amount of time a patient stays alive without the cancer growing) was significantly longer (hazard ratio 0.71, P-value 0.01) in the Adcetris arm (median 48 months, compared to 21 months with CHOP). Overall survival and overall response rates were also significantly better in the Adcetris arm.
