Public health agency the US Food and Drug Administration stated on Friday that it has authorised and 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).
PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells, which spread quickly throughout the body and are hard to treat.
In conjunction, the agency has granted the approval of Adcetris to Seattle Genetics.
This is the first US FDA approval for treatment of newly diagnosed PTCL under its new Priority Review and Breakthrough Therapy designations.
Adcetris is a monoclonal antibody that binds to a protein (called CD30) found on some cancer cells. Adcetris is now approved to treat untreated systemic anaplastic large cell lymphoma (ALCL) and other CD30-expressing PTCLs in combination with chemotherapy. It is approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment, according to the agency.
Additionally, the new approval was based on Seattle's 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 was longer. Overall survival and overall response rates were also better in the Adcetris arm.
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