Bristol Myers Squibb Wins USFDA Approval for Opdivo Combo in Hodgkin 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.

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