More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.In the phase 3 ECHELON-3 study, the addition of Adcetris to lenalidomide and rituximab reduced patients’ risk of death by 37.1% in a group of LBCL patients who had failed on a median three lines of therapies. Compared with the doublet treatment, the Adcetris triplet extended patients’ median survival time by 5.3 months to 13.8 months.
The Adcetris-containing combo also pared down the risk of disease progression or death by 47.3%, according to results presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2024.
The overall survival benefit was seen across various patient subgroups, including those with low CD30 expression and patients who had previously received a CAR-T cell therapy. All patients enrolled in ECHELON-3 were no longer considered candidates for CAR-T or stem cell transplants.
Although CD19 CAR-T meds such as Gilead Sciences’ Yescarta and Bristol Myers Squibb’s Breyanzi are also approved as third-line treatments for certain types of LBCL, it appears Pfizer is not trying to directly compete with them in this instance. Instead, the company chose to study Adcetris in patients who are not able to get those complicated therapies.
The new Adcetris triplet, with its overall survival benefit, could address the high unmet need in patients with previously treated LBCL, “particularly those who are not able to receive CAR T-cell therapy or bispecific antibodies or have [relapsed or refractory] disease following these treatments,” the ECHELON-3 investigators said in an ASCO presentation.
Adcetris came to Pfizer already a blockbuster by way of the company’s $43 billion acquisition of ADC specialist Seagen in 2023. Takeda holds rights to commercialize Adcetris outside the U.S. and Canada.
In 2024, Pfizer recorded Adcetris revenues—including product sales and royalties—of $1.1 billion.
Lately, the blood cancer drug has been overshadowed by another ADC from the legacy Seagen portfolio, the Nectin-4-targeted Padcev. Thanks to a first-line approval in bladder cancer, Padcev’s sales zoomed past Adcetris last year to reach nearly $1.6 billion.