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CHMP recommends Novartis' CAR-T therapy Kymriah for EU approval

Image Credit: Novartis

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T therapy Kymriah (tisagenlecleucel, formerly CTL019).

The blood cancer treatment gained FDA approval in August 2017 having initially been developed by researchers at the University of Pennsylvania. Following a recommendation from the CHMP, the CAR-T cell therapy will now be reviewed by the EMA for approval in the European Union.

FDA places hold on Ziopharm CAR-T trial

CAR-T is emerging as one of the most potentially exciting therapies in the industry, particularly as a beacon for the collective push towards personalised treatment, so it is unsurprising that many small biotechs are currently pursuing treatments within this space.

Gilead seals $3bn deal, hoping for off-the-shelf CAR-T

The expense and laborious process involved in bringing CAR-T therapies to patients was used a key reason for the high cost of the treatments; now, the next step in the field is to find a way to speed up this process, whoever gets there first will have a big advantage.

With this in mind, Gilead has signed a deal with Sangamo Therapeutics that could be worth over $3 billion for the latter company, in a bid to strengthen its acquisition of Kite to gain a position on the market.

Celgene confirms rumours, with $9bn deal for Juno

It seems like 2018 may well be the year for M&A that everyone had expected, as two major deals on the same day announced that acquisitions were back with a bang.

First, Sanofi managed to achieve a long-held goal of making a sizeable addition to its business and now Celgene has made the plunge to acquire Juno Therapeutics in a $9 billion deal.

Celgene rumoured to be revving up for Juno buyout

Celgene has already started off the year with a bang, announcing a deal with Impact Biomedicines worth a potential $7 billion, and it is reported that it is already in the process of making its second big acquisition of the year.

Gilead makes $567m strategic acquisition for next-gen CAR-T

It’s only four months since Gilead completed its buy-out of Kite Pharma for $11.9 billion, but it’s already moving quickly to establish bolt-on technology to take its CAR-T therapy forward.

The first move in this process has been to acquire Cell Design Labs in a deal worth up to $567 million. The technology that Gilead will acquire could see it use Cell Design’s platforms to engineer CAR-T therapy to make currently elusive targets more viable, such as in other forms of cancer.

Cellectis given another shot at off-the-shelf CAR-T

A Cellectis research facility. IMAGE: Cellectis.

It is easy to forget the very real dangers that CAR-T treatment present to patients after Novartis and Gilead both successfully scored approvals on the back of impressive data, and with Juno Therapeutics recently posted potential best-in-class statistics in a recent trial.

Novartis aims for CAR-T double-approval in Europe

Just last week Novartis revealed it had applied to the FDA for a new indication in diffuse large B-cell lymphoma (DLBCL) for its CAR-T treatment, Kymriah, now the company has gone to the EMA hoping to secure two indications at the same time – jump starting its presence in the European market.

The other indication it is applying for is in acute lymphoblastic leukaemia (ALL), the type of blood cancer that Kymriah has already received approval for by the FDA.

CAR-T is bringing true precision to the fight against cancer

Published on 01/11/17 at 11:28am
Image credit: Novartis

Matt Fellows investigates how the first-ever CAR-T therapy approvals in the past months could mean the field of cancer treatment is changed forever

To this day, cancer still remains one of the greatest challenges for healthcare professionals around the world. In all of its forms, the disease is one of the leading causes of death globally, accounting for almost one in six deaths worldwide, claiming the lives of 8.8 million in 2015 alone, according to statistics published by the World Health Organization.

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