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

Novartis’ faulty data scandal dominated the headlines this week, as the Swiss firm faced fierce backlash over covering up the use of bad data in getting its $2.1 million gene therapy Zolgensma approved by the FDA. While executives at Novartis subsidiary AveXis were kicked out, the US Senate demanded answers.

Gilead's CAR-T therapy Yescarta rejected for NHS use in Scotland

It’s bad news for Scottish patients living with aggressive forms of non-Hodgkin lymphoma (NHL) as it emerges that the Scottish Medicines Consortium has chosen to reject Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel).

The decision means that patients who may have exhausted all other avenues of treatment will not be able to receive the treatment on the NHS in Scotland, with many not expected to survive longer than six months in these cases.

NICE give go-ahead to Gilead's Yescarta for adults with lymphoma

The NHS cost effectiveness body NICE has approved Gilead’s Yescarta for treatment of come adults with lymphoma.

Gilead’s treatment will be funded through the Cancer Drugs Fund for adults with relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, two aggressive subtypes of non-Hodgkin lymphoma.

Gilead's CAR-T therapy Yescarta shows two-year response duration in large B-cell lymphoma

Gilead has gone head to head with Novartis at the American Society of Hematology (ASH) Annual Meeting 2018, meeting the latter’s reveal of data on rival Kymriah with study findings of its own CAR-T therapy Yescarta (Axicabtagene Ciloleucel).

The findings revealed that after a minimum follow-up of two years after a single Yescarta infusion – and a median follow-up of 27.1 months – 39% of participants achieved an ongoing response in the treatment of refractory large B-cell lymphoma; in this group, 93% of those experiencing response at 12 months went on to maintain a response after 24

NHS England appoves Gilead's CAR T therapy Yescarta

Gilead’s CAR T therapy Yescarta is set to be made available on the NHS in England for adults with aggressive non-Hodgkin lymphoma, it was announced today.

Although NICE rejected the £300,000 per patient treatment in August of this year, NHS England has come to a confidential agreement with Yescarta manufacturer Gilead Sciences.

Thus an estimated 200 patients a year could benefit from the personalised treatment according to NHS England.

Novartis' Kymriah & Gilead's Yescarta become first EU-approved CAR T therapies

Almost one full year since the treatment was given a “historic” approval in the US, Novartis’ CAR T therapy Kymriah (tisagenlecleucel) has been awarded marketing authorisation in the EU for the treatment of blood cancer. Its rival, Gilead/Kite Therapeutics’ Yescarta (axicabtagene ciloleucel) has also been authorised, marking the first approval of its kind in the region.

As CAR-T therapies, both are manufactured from immune cells derived from a specific patient’s body.

Novartis becomes first to gain second CAR T indication

Novartis has announced that its CAR T treatment, Kymriah, has successfully been given a second indication for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of treatment.

The approval brings Kymriah into the same market space occupied by Gilead’s rival treatment, Yescarta. Most importantly for Novartis, It opens up a new patient pool and will see sales of the drug increase, after a sluggish start to life on the market.

Gilead aims to claim edge with Pfizer CAR-T combo

Although those in pharma often dislike any references to drugs competing with each other for market as in a ‘race’, it’s inevitable that such allusions will be drawn between rivals.

Gilead’s recent acquisition, Kite Pharma, is one of two CAR-T therapies to receive approvals, alongside Novartis’ Kymriah, and comparing it to an arm’s race is the temptation. If that were the case, Kite’s recent team up with Pfizer looks set to test whether its treatment can go nuclear on refractory large B-cell lymphoma.

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.

Gilead gets FDA nod for revolutionary blood cancer treatment

Only weeks after Gilead announced the completion of Kite, it got the news it was hoping for with the FDA's approval for the CAR-T therapy, Yescarta, to become only the second treatment on the market.

The therapy still has a way to go to recoup the $12 billion Gilead agreed to takeover Kite, however, with a price $373,000 per treatment and an ability to expand the indication, it’s looking like a sound deal – investors seem to agree, with shares up 4%.

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