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Novartis' CAR-T Poised For The Market After Unanimous FDA Adcomm Review

Executive Summary

FDA's Oncologic Drugs Advisory Committee recommends 10-0 the agency approve Novartis' tisagenlecleucel (CTL019) for pediatric leukemia in a panel review that was hailed by some in the industry as historic.

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Rising Tide Lifts All CAR-T Ships After Gilead/Kite Deal, Kymriah Approval

Excitement around cell therapy has been building in recent years, but companies expect interest to accelerate after Gilead agreed to buy Kite for $11.9bn and Novartis won the first ever CAR-T approval.

Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.

What's Next On Gilead's Shopping List

With much of its cash held ex-US, Gilead is unlikely to undertake another large acquisition soon, even if there are logical reasons to bolster its NASH pipeline or try to acquire partner Galapagos. Firm is likely to follow Kite buyout with targeted cancer deals.

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