Brentuximab Vedotin Receives FDA Approval for Lymphoma

Today, the FDA granted approval to brentuximab vedotin (Adcetris) for the treatment of patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF), according to a press release.

“Cutaneous T-cell lymphoma is a blood cancer of the skin with no known cure and few new treatment options,” Susan Thornton, cutaneous lymphoma patient and chief executive officer of the Cutaneous Lymphoma Foundation, said in a press release. “It is a disfiguring disease in dire need of more effective and durable treatment options to help keep this debilitating and painful disease at bay.”

The approval was based on positive findings from the ALCANZA phase 3 clinical trial. Included in the study were patients with 131 pcALCL or MF previously administered systemic therapy. Patients were randomized 1:1 to receive brentuximab vedotin or methotrexate or bexarotene (physician’s choice).

The efficacy of brentuximab vedotin was assessed by improvement in objective response rate for 4 months (ORR4), complete response (CR) rate, and progression-free survival (PFS).

The investigators found that brentuximab vedotin significantly improved ORR4, which was achieved by 56% of patients versus 12% in the physician’s choice cohort, according to the release.

Additionally, 16% of patients on brentuximab vedotin achieved CR, while only 2% of patients treated with their physician’s choice of drug achieved CR.

PFS was also improved, with brentuximab vedotin-treated patients reaching 17 months without progression and only 4 months in the physician’s choice cohort, according to the release.

These findings suggest that brentuximab vedotin may be a more effective therapy for pcALCL or MF compared with methotrexate or bexarotene.

“Our phase 3 ALCANZA clinical trial evaluating Adcentris in patients with pcALCL and MF, which are the most common types of cutaneous T-cell lymphoma (CTCL), demonstrated superior efficacy with durable responses for long-term disease management when compared to standard of care treatment options methotrexate and bexarotene,” said Clay Siegall, PhD, president and chief executive officer at Seattle Genetics.

The FDA warns that common adverse reactions for brentuximab vedotin include anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. Peripheral neuropathy was the adverse event that commonly led to treatment discontinuation, according to the release.

Brentuximab vedotin was previously granted breakthrough therapy, orphan drug, and priority review designations. Previously, the drug was approved for classical Hodgkin lymphoma and anaplastic large cell lymphoma, according to Seattle Genetics.

“These data, along with data from investigator-sponsored clinical trials, led to the FDA approval of ADCETRIS as a treatment for patients with pcALCL or CD30-expressing MF, which represent the most common subtypes of CTCL,” Dr Siegall said. “This FDA approval, which was granted more than a month in advance of the PDUFA date, represents a significant milestone for the lymphoma community. Our goal is to establish ADCETRIS as the foundation of care in CD30-expressing lymphomas and this approval represents our fourth FDA-approved indication.”