FDA Expands Approval for Two Drugs to Treat Blood Malignancies


The US Food and Drug Administration has expanded approvals of therapies for anaplastic large cell lymphoma (ALCL) and chronic myeloid leukemia (CML).

Brentuximab vedotin (Adcetris, Seattle Genetics) is an antibody-drug conjugate targeting CD30 now approved for adults with primary cutaneous ALCL or CD30-expressing mycosis fungoides who have received prior systemic therapy. In a recent phase III trial, brentuximab vedotin demonstrated superior 4-month objective response rate, complete response rate, and progression-free survival compared with physician’s choice of methotrexate or bexarotene.

The FDA had previously granted priority review to brentuximab vedotin for the treatment of cutaneous T-cell lymphoma in August.


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Additionally, the FDA has expanded the indication of dasatinib tablets (Sprycel, Bristol-Myers Squibb) to include the treatment of children with Philadelphia chromosome-positive CML in chronic phase.

The safety and efficacy of dasatinib in pediatric patients was assessed in two studies (NCT00306202 and NCT00777036) involving a total of 97 patients with chronic phase CML.

Approval for dasatinib in pediatric patients with Philadelphia chromosome-positive CML in chronic phase was originally granted priority review. The indication received further orphan drug designation before its latest approval.—Zachary Bessette