Expanded Indication for Adcetris
November 16, 2018 – The U.S. FDA has approved an expanded indication for Adcetris® (brentuximab vedotin) injection, manufactured by Seattle Genetics. The drug is now indicated for use in combination with chemotherapy to treat adult patients who have certain types of peripheral T-cell lymphoma (PTCL). Adcetris is the first drug to receive FDA approval to treat newly diagnosed PTCL.
Under the new indication, Adcetris may be used in patients who have previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing PTCL. This includes angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. It should be used in combination with chemotherapy – specifically cyclophosphamide, doxorubicin, and prednisone (CHP).
Patients treated with Adcetris and CHP had improved rates of progression-free survival and overall survival in clinical trials compared to patients treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Adcetris plus CHP also produced statistically significant gains in complete remission rates and objective response rates.
Originally approved by the FDA in 2011, Adcetris is indicated to treat multiple forms of lymphoma, including classical Hodgkin lymphoma. Recommended dosing varies by indication. The drug is administered as an intravenous infusion over the course of 30 minutes and comes in single-dose vials containing 50mg of lyophilized powder each. A black box warning cautions that treatment with Adcetris is associated with JC virus infection that can lead to progressive multifocal leukoencephalopathy (PML), a serious condition that affects the brain and can lead to permanent disability.