FDA Approves First Therapy for Newly Diagnosed PTCLs

PTCLs pic
PTCLs
Image: medscape.org

Trained at New York Medical College and the now-dissolved University of Medicine and Dentistry of New Jersey, Dr. Matthew Taub is a board-certified oncologist based in Florida. Drawing on decades of experience, Dr. Matthew Taub provides evidence-based medical treatment in accordance with guidelines published by the National Cancer Committee Network for a wide range of cancers.

Until recently, no FDA-approved treatment existed for patients with newly-diagnosed CD30-expressing peripheral T-cell lymphomas (PTCLs). Now, the FDA recommends treating PTCLs using brentuximab vedotin injection in conjunction with chemotherapy. This conclusion was made within two weeks of submission to the agency due to the new Real-Time Oncology Review (RTOR) program. Intended to expedite the clinical availability of lifesaving treatments, the RTOR was just launched this past July.

The FDA looked at the ECHELON-2 clinical trial involving 452 patients with PTCLs when it made its decision. Patients in the trial received standard chemotherapy or chemotherapy with brentuximab vedotin injection. In the later arm of the study, patients experienced a median of 48 months of progression-free survival compared to 21 months for the control group with a P-value of 0.01.

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