FDA clears new indication for Adcetris
The Food and Drug Administration today expanded the use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma, or PTCL.
This is the first FDA approval for treatment of newly diagnosed PTCL. The FDA granted this application Priority Review and Breakthrough Therapy designation.
PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells. The T-cells often spread quickly throughout the body and are hard to treat.
Adcetris is a monoclonal antibody that binds to a protein called CD30 found on some cancer cells.
Adcetris is now approved to treat previously untreated systemic anaplastic large cell lymphoma, or ALCL, and other CD30-expressing PTCLs in combination with chemotherapy.
Adcetris was previously approved by the FDA to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma, or cHL; cHL after relapse; cHL after stem cell transplant when a patient is at a high risk of relapse or progression; systemic ALCL after failure of other treatment; and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.
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