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BMS therapeutic cancer vaccine given swift FDA appraisal

pharmafile | September 29, 2014 | News story | Sales and Marketing BMS, Bristol-Myers Squibb, Cancer, FDA, Vaccine, bristol myers-squibb, keytruda, melanoma, opdivo 

Bristol-Myers Squibb has been granted a speedy review for its new cancer immunotherapy drug Opdivo by the FDA for patients with the deadliest form of skin cancer.

The drug is one of a new class of cancer medicines called PD-1 inhibitors that can help the body’s immune system fight certain tumours, and may be worth around $30 billion by the next decade.

It was first approved in Japan in the summer but lost out to Merck’s Keytruda (pembrolizumab) when it became the first PD-1inhibitor to gain an FDA approval earlier this month, where it too gained a licence for melanoma.

Bristol-Myers Squibb will now be second to market, should its drug gain approval, which could be as early as 30 March next year.

BMS should still see blockbuster sales at its peak for Opdivo (nivolumab) with Keytruda also expected to make around $1.7 billion at its height, although Merck’s medicine may make more given its first-to-market status.

New trial data

But BMS will hope its new data for the vaccine published this week may help shore up its defences against Merck’s new medicine.

The company touted new data at the ESMO European cancer congress today, which showed that in patients with advanced melanoma, 32% saw their tumours shrink when given Opdivo against 11% of those treated with conventional chemotherapy drugs.

The duration of response was also much longer as patients on chemotherapy typically responded for 3.6 months, whereas 95% of those who responded to Opdivo were still benefiting after six months and the median duration of response was not reached.

There was not any head-to-head between Opdivo and Keytruda however, although analysts were still impressed by the duration of response rates, which are important in real-world terms.

EMA application

The firm also says this week that the EMA has accepted for review a new application for its PD-1 drug for patient with certain type of lung cancer.

This is the first company to apply for a licence in non-small cell lung cancer using this new class of medicine; it has already submitted its melanoma licence to the European regulators, although it looks likely that Merck will steal a march on the firm here, too.


But things have become ugly between Merck and BMS after the latter firm began legal action against its fierce US rival the day it received FDA approval for Keytruda.

In its lawsuit filed in the US District Court of Delaware, BMS said that Merck was planning to ‘exploit its invention’ of its new immunotherapy drug nivolumab with Keytruda, arguing that it is violating the company’s 20 May patent.

The alleged infringement relates to BMS’s patent that allows its drug to treat cancer with anti-PD-1 antibodies. Specifically, this is its 474 patent relating to how its antibody binds to the PD-1 and blocks the checkpoint pathway.

Merck has dismissed the claims however, and says it will still roll-out its drug in the US as planned.

Ben Adams 

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