FDA’s approval of a new combination treatment for patients with classical Hodgkin lymphoma (cHL) is the first new advanced treatment for the disease in 40 years.
FDA recently okayed brentuximab vedotin (Adcetris, Seattle Genetics) to treat adult patients with previously untreated stage 3 or state 4 cHL in combination with chemotherapy.
“Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in an FDA statement. “This approval demonstrates our commitment to approving advancements in treatment that give prescribers and patients different options for care.”
Around 8,260 people in the US were diagnosed with Hodgkin lymphoma last year and approximately 1,070 patients with non-Hodgkin lymphoma died from the disease in 2017, according to the National Cancer Institute at the National Institutes of Health.
Adcetris’s approval is based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared Adcetris plus AVD (Adriamycin, vinblastine and dacarbazine) to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). The treatment combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30, according to FDA.
“The standard of care for treating newly diagnosed advanced Hodgkin lymphoma has not changed in more than four decades. For years, the physician community has been conducting clinical trials to identify improved regimens that are both less toxic and more effective to no avail,” said Joseph M. Connors, MD, FRCPC, clinical director of the Center for Lymphoid Cancer at BC Cancer in Vancouver, Canada, in a Seattle Genetics statement.
“The ECHELON-1 study results demonstrated superior efficacy of the ADCETRIS plus chemotherapy regimen when compared to the standard of care while removing bleomycin, an agent that can cause unpredictable and sometimes fatal lung toxicity, completely from the regimen,” Connors added.
This is the fifth FDA-approved indication for Adcetris, which also has regular approval for adult patients with: (1) classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (2) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (4) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Adcetris has a boxed warning that highlights the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection that can result in death.
Serious risks of Adcetris include peripheral neuropathy; severe allergic (anaphylaxis) or infusion-site reactions; damage to the blood, lungs and liver (hematologic, pulmonary and hepato-toxicities); serious or opportunistic infections; metabolic abnormalities (tumor lysis syndrome); serious dermatologic reactions and gastrointestinal complications.