FDA to review Bristol-Myers’ Opdivo for classical Hodgkin lymphoma

The agency will review the submission under priority review status which reduces the review time to six months from the standard 10 months.

In May 2014, the FDA granted breakthrough therapy designation for the indication.

The data supporting the sBLA was generated in the CheckMate-205 study, which assessed the safety and efficacy of Opdivo in patients with relapsed or refractory cHL.

Full results are due to be presented at a medical conference later this year.

Bristol-Myers Squibb oncology global clinical research lead Jean Viallet said: "There is a significant burden on classical Hodgkin lymphoma patients who do not respond to initial treatment, and they need new treatment options that address the disease in a different way.

"With the Agency’s acceptance of our application, Opdivo has the potential to be the first PD-1 inhibitor in hematology, allowing us to expand Immuno-Oncology beyond solid tumors to patients with classical Hodgkin lymphoma and strengthen our hematology franchise."

Opdivo targets the cellular pathway known as PD-1/PD-L1 proteins identified on the body’s immune cells and various cancer cells. The blocking of the pathway helps the body’s immune system fight cancer cells.

It is currently approved to treat kidney cancer, melanoma and squamous non-small cell lung cancer.

Opdivo currently has regulatory approval in 48 countries, including the US, Japan and in the European Union.

Earlier this month, the European Commission approved new indications for Opdivo, expanding its use in the treatment of non-small-cell lung cancer, and adding the indication of renal cell carcinoma.

Image: Bristol-Myers Squibb facility in Syracuse, New York, US. Photo: courtesy of Bristol-Myers Squibb Company.