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Roche claims its own CAR-T first with orphan drug Actemra

Comes as FDA approves the first CAR-T therapy from Novartis

Roche

The US Food and Drug Administration (FDA) has given a green light for Roche’s Actemra (tocilizumab) for the treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS) in patients two years and older.

The decision coincided with this week’s US approval for the first CAR-T therapy - Novartis’ Kymriah - and the new approval is a big win for Roche, as its intravenous injection is the first and currently only approved medication for CAR-T associated CRS.

The condition is caused by an overactive immune response and has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy.

Sandra Horning, chief medical officer and head of global product development, Roche, said: “Until today there has never been an FDA-approved treatment to manage severe CRS associated with CAR T Cell therapy, which is marked by a rapid onset and can cause life-threatening complications.

“The approval provides physicians with an important tool to help manage this potentially life-threatening side effect.”

Due to the rare, severe and life-threatening nature of CRS, alongside outcome data from clinical trials the FDA also gave the medication orphan drug status.

The trial, which included 45 paediatric and adult patients, was treated with Actemra with or without additional high-dose corticosteroids for severe of life-threatening CRS.

It saw 31 patients achieved a resolution of CRS within 14 days of the first dose, and no more than two doses of Actemra were needed.

There were also no adverse actions reported from patients taking the injection.

Article by
Gemma Jones

1st September 2017

From: Regulatory

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