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Gilead gets FDA nod for revolutionary blood cancer treatment

Published on 19/10/17 at 08:59am

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%.

The one-time treatment’s price had been a source of interest, after Novartis’ CAR-T treatment coming in at $475,000, most assumed that Gilead would have to arrive at a lower price. The price settled on is on the lower side of expectation, but this is partially due to the higher numbers of patients eligible for the treatment.

One aggressive caveat Novartis had included in its own treatment saw it agree that if patients did not respond to treatment within a month, there would be no charge for treatment. For Novartis, this made a good makeweight for the treatment’s high cost, especially considering 83% of patients responded to treatment.

Gilead decided against offering the same deal, despite 82% of patients seeing a response, 36% of patients saw their cancer go into remission. This would seem to be the reason behind the aggressive price – to avoid any pricing debates early into the drug’s lifespan by pitching the price lower compared to its rival rather than tying it to outcomes.

Yescarta will be eligible for patients with a form of non-Hodgkin lymphoma, diffuse large B-cell lymphoma. The condition affects 30,000 people in the US each year, with approximately a third not responding to treatment, which previously would have left them with no treatment options.

“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” said Arie Belldegrun, Founder of Kite. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”

Analysts predict that the treatment could bring in sales of approximately $250 million for Gilead in 2018. At present, one aspect hindering the profitability of such treatment is manufacturing cost but as these drop with time, more profit will be able to be made on the treatment – more than likely increasing debate regarding the price of both Novartis and Gilead’s treatments.

Ben Hargreaves

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