FDA Expands Approval for Two Drugs to Treat Blood Malignancies

11/10/17

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