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Brentuximab vedotin
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) seeking approval for brentuximab vedotin (Adcetris) as a treatment for cutaneous T-cell lymphoma (CTCL).
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA plans to make a decision on the sBLA for brentuximab vedotin by December 16, 2017.
The sBLA is supported by data from the phase 3 ALCANZA trial and a pair of phase 2 investigator-sponsored trials.
About brentuximab vedotin
Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.
Brentuximab vedotin is currently FDA-approved for 3 indications.
The drug is approved to treat patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Brentuximab vedotin initially had accelerated approval for this indication, but it was later converted to full approval.
Brentuximab vedotin also has full approval as consolidation for patients with classical Hodgkin lymphoma who have a high risk of relapse or progression after auto-HSCT.
And the drug has accelerated approval for the treatment of patients with systemic anaplastic large-cell lymphoma (sALCL) after failure of at least 1 prior multi-agent chemotherapy regimen. This accelerated approval is based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Brentuximab vedotin previously received breakthrough therapy designation from the FDA for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous ALCL who require systemic therapy and have received 1 prior systemic therapy.
Brentuximab vedotin also has orphan drug designation from the FDA for the treatment of MF.
