Opdivo to be reviewed in Europe for lung cancer

Bristol-Myers Squibb has announced that its new immunotherapy treatment nivolumab has been accepted for review by the EMA for non-small cell lung cancer (NSCLC).

The EMA has formally accepted the firm’s submission, which puts it in pole position to become the first of the new PD-L1/ PD-1 immunotherapy drugs to gain a licence in lung cancer, one of the most common cancers.

Nivolumab, known under the brand name of Opdivo, is slightly different from its competitors in targeting PD-1 (expressed on the tumour cells) rather than PD-L1, (expressed on the body’s immune cells) but uses the same principle of activating the body’s own immune system to help fight tumours.

Merck’s rival PD-L1 Keytruda (pembrolizumab) won the race to be first approved in the US in early September against melanoma, while Opdivo gained approval in Japan in July for the same use.

Both Keytruda and Opdivo have been filed with the EMA for use again melanoma, with Merck just one month ahead of BMS.  But if any of the new class of drugs can demonstrate significantly better outcomes in lung cancer than existing treatments, they will almost certainly multi-billion dollar sales worldwide.

“Lung cancer is the leading cause of cancer death worldwide, and there remains a significant need for effective treatment options for patients with this disease,” said Dr Michael Giordano, senior vice president, head of oncology development, BMS.

“We are pleased to have two applications for nivolumab now under review in the EU, and look forward to continued collaboration with health authorities around the world as we work to bring nivolumab to patients.”

The MAA submitted to the EMA in lung cancer is based on data from the phase II study of nivolumab in third-line pre-treated squamous cell NSCLC (Study -063).

BMS has begun a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.


The immunotherapy drugs have been among the most talked about new treatments at Europe’s annual cancer congress ESMO.

Phase III data presented today from another study showed that nivolumab achieved superior response rates and a longer duration of response than standard chemotherapy in patients whose melanoma has progressed after treatment with BMS’ existing melanoma drug Yervoy (ipilimumab).

Merck yesterday presented new phase II data on its drug in advanced gastric cancer, as well as phase 1b data in NSCLC.


CORRECTION: Please not the original version of this article published yesterday (29 September) stated that nivolumab had been approved in Europe. The article has now been updated to correct this error.


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