FDA approves brentuximab vedotin to treat 2 types of lymphoma

FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.

Brentuximab vedotin is indicated for:

• The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
• The treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least 1 prior multi-agent chemotherapy regimen

The indications for brentuximab vedotin are based on response rate. There are no data available that demonstrate improvement in patient-reported outcomes or survival with brentuximab vedotin. The first drug approved by FDA for Hodgkin lymphoma in more than 30 years, brentuximab vedotin provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings.

Brentuximab vedotin is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

“We are committed to continued clinical investigation of Adcetris through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA," said Clay B. Siegall, PhD, president and CEO of Seattle Genetics, in a company press release.

The effectiveness of brentuximab vedotin in patients with Hodgkin lymphoma was evaluated in a single clinical trial involving 102 patients. In the single-arm trial, patients were treated only with brentuximab vedotin. The study's primary end point was objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.

The effectiveness of brentuximab vedotin in patients with systemic anaplastic large cell lymphoma was evaluated in a single clinical trial in 58 patients. In the single-arm trial, patients were treated only with brentuximab vedotin. Similar to that of the Hodgkin lymphoma trial, the trial's primary end point was objective response rate. Of the patients receiving brentuximab vedotin for systemic anaplastic large cell lymphoma, 86% experienced either a complete or partial response and responded on average for 12.6 months.

The most common side effects experienced with brentuximab vedotin were a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels (thrombocytopenia).

Pregnant women should be aware that brentuximab vedotin might cause harm to an unborn baby.

"The marked single-agent activity seen with Adcetris, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated," said Owen A. O'Connor, MD, PhD, professor and director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "This approval represents a major advancement in the care of these patients."

Seattle Genetics expects to make brentuximab vedotin available to patients next week.

Seattle Genetics also announced that it has established a patient assistance program, titled SeaGen Secure, that offers patients and providers access to brentuximab vedotin reimbursement support, benefit investigations, and patient assistance programs.