Pfizer’s Takeda-partnered blood cancer drug Adcetris (brentuximab vedotin) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for large B-cell lymphoma (LBCL).
The antibody-drug conjugate (ADC) has been authorised for use alongside lenalidomide and a rituximab product to treat adults with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, arising from indolent lymphoma, or high-grade B-cell lymphoma.
Patients eligible for the CD30-directed drug must also have received at least prior two lines of systemic therapy and will not be eligible for autologous haematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy.
LBCL is a form of non-Hodgkin lymphoma, a type of cancer that starts in the lymphocytes and affects immune cells called B lymphocytes. Up to 70% of LBCL patients have advanced disease at diagnosis, and more than 3,500 patients a year fail two prior lines of therapy and require third-line treatment.
Adcetris belongs to a relatively new class of cancer drugs that combine the selectivity of antibodies with the cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones.
The FDA’s decision to approve Adcetris for its eighth indication was based on positive results from the late-stage ECHELON-3 study, in which Adcetris plus lenalidomide and rituximab reduced patients’ risk of death by 37% compared to placebo in combination with lenalidomide and rituximab.
The overall survival benefit was consistent across levels of CD30 expression, Pfizer said, adding that positive outcomes were also observed in key secondary endpoints, including progression-free survival and overall response rate.
Pfizer’s chief oncology officer, Roger Dansey, said: “[This] approval further reinforces the important role of Adcetris as an existing standard of care with overall survival improvement shown for certain types of lymphomas, and now allows physicians to have an option beyond chemotherapy or CAR-Ts for patients with relapsed or refractory LBCL.”
Pfizer holds commercialisation rights to Adcetris in the US and Canada, while Takeda is responsible for the drug’s commercialisation in the rest of the world.