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Gilead's CAR-T therapy Yescarta now available via NHS Scotland for two forms of B-cell lymphoma

News has broken that the Scottish Medicines Consortium (SMC) has chosen to approve the use of Gilead’s chimeric antigen receptor T cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel) on the NHS in Scotland.

Top Ten most popular articles on Pharmafile.com this week!

This week’s top story covered the scandal surrounding Novartis over its covering up of faulty data from the FDA. The Swiss firm’s integrity was called into question after it waited until it’s $2.1 million gene therapy had been approved before informing the US regulator of inaccuracies in its data.

Novartis' Kymriah to be covered by Japan's national insurance system

Japan’s national medical insurance system will pay for Novartis’ CAR-T therapy Kymriah following approval from the Central Social Insurance Medical Council.

Kymriah, which costs 33.49 million yen ($305,455), will be covered by Japan’s national health insurance from the 22 May. Kymriah will thus become the most expensive treatment covered by Japan’s system.

Coverage will however be limited to leukaemia patients under the age of 25 who have failed to respond to other therapies.

Canada Health approves Novartis' CAR-T therapy Kymriah

Health Canada has approved Novartis’ CAR-T therapy Kymriah for use in paediatric and young adult patients aged between three and twenty-five years old with B-cell acute lymphoblastic leukaemia (ALL) and for adults with relapsed or refractory (r/r) large B-cell lymphoma.

However the one time treatment, which harnesses the patient’s immune system in the fight against cancer, is expected to cost the Canadian healthcare system more than $400 million over three years.

Merck KGaA hands over CAR-T therapy business to Intrexon in deal worth $175 million

German pharma firm Merck KGaA has agreed to hand over its CAR-T therapy business to US company Intrexon in a deal worth $175 million.

Intrexon will hand over $150 million in stock and a $25 million convertible note. The company will in turn receive a $25 million cash investment. Thus Merck will maintain an investment in the next generation of CAR-T therapies.

The new deal comes three years after Merck forged a $941 million deal with Intrexon in 2015. Merck has characterised the move as an attempt to streamline their R&D processes.

20 year old man died after leukaemia cell was accidently mixed into CAR T therapy

Image Credit: Jimjamjak

A 20 year old man died after a single leukaemia cell accidentally ended up in a batch of cells that were being manufactured into a CAR-T cell therapy, according to researchers at the University of Pennsylvania.

The mistake, which brought about a fatal relapse in the 20 year old man, was reported in the journal Nature Medicine.

The patient was entered into an early stage trial of CTL019, which was eventually licensed to Novartis and sold under the brand name Kymriah.  

Novartis strike $40m deal with Chinese firm Cellular Biomedicine

Swiss multinational Novartis have paired up with Chinese drugmaker Cellular Biomedicine (CBMG) in order to manufacture CAR-T therapy Kymriah in the People’s Republic of China (PRC).

The move comes as Novartis seeks to win approval for Kymriah and find its way in the most populous country in the world.

Due to Chinese regulations, Novartis must pair up with a Chinese firm in order access the country’s market and win approval for drugs. As such the Basel-based firm has bought 9% of CBMG’s shares for $40 million.

NICE decision could limit future development of CAR T therapies; Evelyn Warner comments on NICE's decision making process

Lack of access to CAR T therapies in the United Kingdom could hinder the development of effective personalised cancer treatments, according to the London-based data analytics firm GlobalData.

While the National Institute for health and Care Excellence (NICE) approved Novartis’ Kymriah for children with R/R B-cell acute lymphoblastic leukemia at the beginning of September, the regulator rejected the treatment for use in adults with refractory/relapsed (R/R) diffuse large B-cell lymphoma (DLBCL) due to concerns as to the cost effectiveness of the drug.

NICE rejects CAR-T therapy Kymriah for DLBCL in adults

The National Institute for health and Care Excellence (NICE) has rejected Novartis’ CAR-T therapy Kymriah for use in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

While Kymriah was approved for use in children and young adults up to the age of 25 years old with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, earlier this month; the cost effectiveness body have chosen not to fund the Swiss multinational’s treatment for adults with DLBCL.

Novartis' CAR T therapy Kymriah to become available on the NHS

Novartis’ Kymriah is set to become the first CAR T therapy to become available on the NHS after it was revealed that the cancer treatment will be offered to children and young adults up to the age of 25 years old with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

While both Gilead and Novartis’ CAR T therapies were awarded marketing authorisation in the European Union just last week, NICE were quick to reject Gilead’s CAR T therapy Yescarta on the grounds that it was too expensive.

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