Seagen Inc...today announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of adult patients with… Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.

ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of adult patients with… Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation… Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates

Hodgkin Lymphoma (Age ≥18 years)...Relapsed/Refractory Disease...CHL...ICE + brentuximab vedotin

Hodgkin Lymphoma: other recommended regimen...Brentuximab vedotin + AVD

Pediatric Hodgkin Lymphoma...Maintenance (post-transplant)...Useful in certain circumstances, for select high-risk patients: Brentuximab vedotin

Pediatric Hodgkin Lymphoma...Re-Induction Therapy Options...Brentuximab Vedotin+bendamustine

Pediatric Hodgkin Lymphoma...Re-Induction Therapy Options...Brentuximab vedotin+gemcitabine.

Hodgkin lymphoma: Second-line options…Brentuximab vedotin

Hodgkin Lymphoma: CHL, Second-line option added:...Brentuximab vedotin + bendamustine

OS significantly favored A+AVD vs ABVD (HR 0.590; 95% confidence interval [CI] 0.396–0.879; p = 0.009). Estimated 6-year OS rates (95% CI) were 93.9% (91.6–95.5) vs 89.4% (86.6–91.7) with A+AVD vs ABVD, respectively. There was a consistent OS benefit for A+AVD vs ABVD across prespecified subgroups. The 6-year PFS estimate was 82.3% (79.1–85.0) vs 74.5% (70.8–77.7) with A+AVD vs ABVD, respectively (HR 0.678 [95% CI 0.532–0.863]).

Seagen Inc...phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy...patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

ECHELON-1 was an international, open-label, randomised, phase 3 trial done at 218 clinical sites...At a median follow-up of 60·9 months (IQR 52·2–67·3), 5-year progression-free survival was 82·2% (95% CI 79·0–85·0) with A+AVD and 75·3% (71·7–78·5) with ABVD (hazard ratio [HR] 0·68 [95% CI 0·53–0·87]; p=0·0017)...With 5 years of follow-up, A+AVD showed robust and durable improvement in progression-free survival versus ABVD, regardless of PET-2 status, and a consistent safety profile. On the basis of these findings, A+AVD should be preferred over ABVD for patients with previously untreated stage III or IV classical Hodgkin lymphoma.

At a median follow-up of 24.6 months, 2 year modified progression-free survival rates in the A+AVD and ABVD groups were 82.1% (95% confidence interval [CI], 78.8 to 85.0) and 77.2% (95% CI, 73.7 to 80.4), respectively...664 were assigned to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) and 670 were assigned to receive doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).... A+AVD had superior efficacy to ABVD in the treatment of patients with advanced-stage Hodgkin's lymphoma, with a 4.9 percentage-point lower combined risk of progression, death, or noncomplete response and use of subsequent anticancer therapy at 2 years.

...randomly assigned 329 patients to the brentuximab vedotin group (n=165) or the placebo group (n=164). Progression-free survival by independent review was significantly improved in patients in the brentuximab vedotin group compared with those in the placebo group (hazard ratio [HR] 0·57, 95% CI 0·40–0·81; p=0·0013).