March 20 (Reuters) – The U.S. Food and Drug Administration said on Friday it approved Bristol Myers Squibb’s combination treatment for adults and adolescents aged 12 and older with previously untreated stage III or IV classical Hodgkin’s lymphoma.
The therapy, branded as Opdivo, is already approved to treat various advanced or metastatic cancers, including melanoma, non-small cell lung cancer and kidney cancer.
The FDA said the newly approved regimen combines Opdivo with doxorubicin, vinblastine and dacarbazine — collectively known as the AVD chemotherapy regimen — offering a new frontline option for advanced-stage disease.
Hodgkin’s lymphoma, also known as Hodgkin’s disease, is a cancer that starts in white blood cells called lymphocytes, which are key part of the body’s immune system.
It is the most common cancer diagnosed in adolescents aged 15 to 19, the company said.
The approval is based on a late-stage study of 994 patients, which showed the Opdivo regimen significantly improved progression-free survival compared with brentuximab vedotin, marketed by Pfizer’s Seagen unit as Adcetris, plus AVD.
Serious adverse reactions occurred in 39% of patients receiving the Bristol Myers’ combo, and immune-mediated reactions were reported in 9%.
Opdivo belongs to a fast-growing class of drugs called PD-1 inhibitors, a type of immunotherapy that helps the immune system attack cancer by blocking a mechanism tumors use to evade detection.
The FDA also converted Opdivo’s earlier accelerated approvals in relapsed or refractory disease to traditional approvals.
The drug is now fully approved for adults whose cancer returns after a stem-cell transplant and treatment with brentuximab vedotin, or after at least three prior treatments including transplant.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber and Alan Barona)
