Roche nets new Actemra nod to treat deadly CAR-T response

Roche Molecular Diagnostics
Roche's Actemra brought in $1.77 billion in 2016 sales.

Roche’s Actemra has a new use and it’s an important one—both for the med’s own sales and for expansion of the brand-new CAR-T market. 

The FDA has greenlighted Actemra to treat severe or life-threatening cytokine release syndrome (CRS) that’s been brought on by CAR-T therapy. It’s a condition caused by an overactive immune response, and it’s been pegged as a potentially fatal side effect of CAR-T treatment for certain cancers.

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The way Roche Chief Medical Officer and Head of Global Product Development Sandra Horning put it in a statement, the approval “provides physicians with an important tool to help manage this potentially life-threatening side effect.” And that means physicians may have fewer reservations about prescribing the therapiesthe first of which, Novartis’ Kymriah, snagged a thumbs up from U.S. regulators Wednesday.

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There may soon be another CAR-T med on the scene that Actemra can boost, too. Kite Pharma—which recently agreed to an $11.9 billion Gilead buyouthas an FDA decision date coming up in November for its contender, Axi-Cel.

The new use, meanwhile, will also give Actemra and Roche’s portfolio a lift. The med was already providing growth for the Swiss drugmaker; last year, sales swelled 16% to CHF 1.7 billion ($1.77 billion), helped by expansion of its subcutaneous formulation. Overall, it helped push the company’s pharma sales up by 3% to CHF 39.1 billion ($40.72 billion).