BMS applies for Hodgkin's Lymphoma use for Opdivo in US


Bristol-Myers Squibb is looking to further expand the use of its Opdivo cancer immunotherapy, applying to the US regulator for a new indication in classical Hodgkin Lymphoma after prior therapies.

BMS has filed the drug in cHL patients who have received autologous stem cell transplants and Takeda/Seattle Genetics' Adcetris (brentuximab vedotin).

DrugAnalyst research forecasts Opdivo (nivolumab) will generate sales of more than $8.2 billion in 2020. In the last quarter of 2015 sales were $475 million.

The latest filing, based on the CheckMate -25 study, is further proof that Opdivo's sales will be boosted by its uses across different cancers. Last year alone the drug had seven FDA approvals across three tumour types.

BMS said the US Food and Drug Administration had granted a priority review lasting six months instead of the standard ten months. This followed the FDA's decision in 2014 to grant Opdivo Breakthrough Therapy designation for cHL, indicating the drug shows promise in a serious or life-threatening conditon and could be better than existing options.

Like Merck & Co's rival, Keytruda (pembrolizumab), Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells.

It blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway's suppressive signalling on the immune system, including the interference with an anti-tumour immune response.

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15 April, 2016