The agency has yet to authorize Adcetris for CTCL. A supplemental Biologics License Application that Seattle Genetics filed asks the FDA to approve the therapy for an additional set of CTCL patients who were not in the original application.
“The submission of the supplemental BLA (application) requesting label expansion for Adcetris as a treatment in CTCL patients who require systemic therapy is an important milestone,” Dr. Jonathan Drachman, Seattle Genetics’ chief medical officer, said in a press release.
“CTCL is an incurable and disfiguring disease in need of new therapeutic options, particularly those that achieve durable responses,” he added.
The FDA granted Breakthrough Therapy Designation to Adcetris in November 2016. The authorization covered patients with CD30-positive mycosis fungoides and cutaneous anaplastic large cell lymphoma who had received one previous systemic therapy.
CD30 is a protein found in some immune-system T-cells and B-cells that is associated with the development of lymphomas. A systemic therapy is one that travels through the bloodstream to reach cells throughout the body.
The FDA based its decision to grant the Breakthrough Therapy Designation on the basis of preliminary results of the ALCANZA Phase 3 clinical trial (NCT01578499).
Results from two additional trials prompted Seattle Genetics to submit the supplemental Biologics License Application. The Phase 2 trials (NCT01396070 and NCT01352520) supported its contention that Adcetris could help people with other types of CTCL.
“Results from the phase 3 ALCANZA trial demonstrated that CTCL patients treated with Adcetris had superior outcomes across all primary and secondary endpoints [trial objectives] compared to patients in the control arm who were treated with either methotrexate or bexarotene standard of care,” Drachman said.
“In addition to the ALCANZA results, data from two investigator-sponsored trials also support Adcetris use in this disease setting. We believe these data are clinically meaningful and support a label expansion for Adcetris in CTCL, which would be the fourth indication [type of patient group] for this program.”
The ALCANZA trial covered 128 CTCL patients with CD30 protein at 52 centers in 13 countries. Participants were randomly assigned to receive intravenous Adcetris once every 21 days for up to 48 weeks or a standard therapy: methotrexate or bexarotene.
Nearly five times as many patients who received Adcetris for at least four months achieved either a complete or partial response to treatment than those who received either methotrexate or bexarotene, according to an article this month in the journal Lancet. The figures were 56.3 percent for the Adcetris group, versus 12.5 percent for the control arm.
Adcetris-treated patients had more complete responses than those who received standard therapies. It also took longer for them to have their disease progress. And they achieved a greater reduction in symptoms than the controls.
Overall, patients tolerated Adcetris well, and its safety profile was consistent with previous reports. The most common treatment-related adverse events were peripheral nerve damage, nausea, diarrhea, fatigue, vomiting, and hair loss.
The FDA, Health Canada and the European Commission have approved Adcetris for treatment of certain relapsed or refractory Hodgkin lymphomas and systemic anaplastic large cell lymphomas.
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