Novartis in major oncology drive

pharmafile | March 30, 2015 | News story | Research and Development, Sales and Marketing Cancer, FDA, MHRA, Novartis, aduro, ceritinib, eams, early access, zykadia 

Novartis says it is ‘stepping up its efforts’ in cancer by launching major initiatives to discover new treatments to combat the disease.

In the UK the company’s lung cancer drug Zykadia (ceritinib) has been given a Promising Innovative Medicine (PIM) designation by the MHRA, who oversee the UK’s Early Access to Medicines Scheme (EAMS).

Being granted PIM status is the first step to inclusion in EAMS, which is aimed at providing faster patient access to innovative medicines for life-threatening conditions.

Recently Merck’s Keytruda became the first drug to be approved for use as a treatment for advanced melanoma through the scheme. The next stage in the process is for Novartis to apply to the MHRA to weigh up the clinical trial data on Zykadia, and decide whether to add it to the scheme.

Zykadia is in development for the treatment of ALK-positive non-small cell lung cancer, which affects 3-7% of people with the disease. It has recently received a positive recommendation for approval in Europe by the EMA for this indication, and is already licensed by the FDA after becoming one of the first medicines to be granted Breakthrough Therapy designation.

“There can often be a lengthy time lag between the submission of marketing authorisation of a medicine and its review by NICE, which can mean that patients with few other options cannot access important new medicines that could transform their outcomes”, says Margaret Dean, Novartis oncology general manager, UK and Ireland.

“Inclusion of ceritinib in the EAMS should support earlier access for these patients that need it without delay. Novartis strongly supports schemes such as this which demonstrate the importance of scientific innovation and drug discovery to the UK government.”

The Swiss firm has also signed a $200 million collaboration with the Danish company Aduro Biotech, which specialises in engineering novel immunotherapy technologies that activate the immune system against cancer that has three products currently in human trials.

The company’s lead candidate – a treatment targeting metastatic pancreatic cancer that combines an immunotherapy called CRS-207 with a candidate cancer vaccine called GVAX – has received breakthrough therapy designation from the FDA.

Novartis will make an upfront payment of $200 million and an initial equity investment of $25 million, with a commitment for another $25 million at a later date. Aduro will lead commercial activities in the US and Novartis in the rest of the world.

The companies will share in profits in the US, Japan and major European countries – and Novartis will pay Aduro a royalty for sales in the rest of the world.

Novartis says the collaboration will “add firepower to its diverse portfolio of immunotherapies”. Its oncology pipeline includes the chimeric antigen receptor T-cell (CAR T- cell) therapy CTL019, which is in Phase II trials, and the checkpoint inhibitors LAG3 and TIM3, which are expected to enter the clinic in the coming months.

It has also launched a new immuno-oncology research group led by cancer vaccine expert Dr Glenn Dranoff, a professor of medicine at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School. 

Lilian Anekwe

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