Clay Siegall, PhD Clay Siegall, PhDThe Food and Drug Administration has awarded brentuximab vedotin (Adcetris) a breakthrough medication designation for the first-line curing of patients by classical Hodgkin lymphoma, Seattle Genetics, the Inc. emerging the antibody-drug conjugate, reported today.Brentuximab vedotin is an antibody-drug conjugate directed to CD30, a defining marker of the disease.
Twenty-six patients received 1.2 mg/kg brentuximab vedotin by AVD.
Determination of antitumor activity was based on Researcher assessment of objective response according to the Revised Response Criteria for Malignant Lymphoma.
At the finish of frontline therapy, 95% of patients assigned to brentuximab vedotin plus ABVD had full response (CR) & 92% of those assigned to brentuximab vedotin plus AVD patients had a CR.
One patient in the brentuximab vedotin plus AVD arm had a partial response & one had progressive disease.One patient in the brentuximab vedotin plus ABVD arm died of hyponatremia & pulmonary toxicity.
FDA Grants Breakthrough medication Designation to Brentuximab Vedotin for Hodgkin Lymphoma
FDA Grants Breakthrough medication Designation to Brentuximab Vedotin for Hodgkin LymphomaShare this content:linkedingoogleEmailPrintThe Food and Drug Administration granted Breakthrough medication Designation to brentuximab vedotin plus chemotherapy as first-line medication for features classical Hodgkin lymphoma.
The 2-year modified progression-free survival (PFS) average was 82.1% & 77.2% for the brentuximab vedotin plus AVD arm & ABVD arm, respectively, demonstrating that the brentuximab combination reliefed the danger of illness progression & dying (hazard ratio [HR], 0.770; P = .035).
Overall survival (OS), the secondary endpoint of the study, trended in favor of the brentuximab plus AVD arm.
Brentuximab vedotin is being more evaluated for the curing of several lymphomas in clinical studies, including ECHELON-2 CheckMate 812
The Food and Drug Administration grants breakthrough medication designation to medications that treat serious conditions for that preliminary results demonstrate clinical benefit.
FDA Gives Adcetris Breakthrough medication case as Firstline Hodgkin’s Treatment
The Food and Drug Administration has granted a breakthrough medication designation to brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination by chemotherapy for the firstline curing of patients by features classical Hodgkin’s lymphoma.
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin’s lymphoma.
Brentuximab vedotin is being evaluated globally as the base of care for CD30-expressing lymphomas in further than 70 clinical trials.
The two-year modified PFS average for patients in the brentuximab vedotin arm was 82.1% compared to 77.2% in the control arm.
Interim test of overall survival, the key secondary endpoint, too trended in favor of the brentuximab vedotin plus AVD arm.
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