Much awaited FDA advisory panel delivers positive vote on CAR-T therapy

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL), Swiss pharma giant Novartis (NOVN: VX) has announced late on Wednesday.

Analysts have forecast peak sales of at least $1 billion for tisagenlecleucel-T, which Novartis is also evaluating for other indications. "This will be a historic approval," said Brad Loncar, chief executive of Loncar Investments which runs the Loncar Cancer Immunotherapy ETF, quoted by the New York Times. "As an investor I've never seen anything like it. It's an entirely new way of treating cancer."

Novartis's stock closed up 1.5% at $83.21 in US trading yesterday, but was virtually unchanged in Swiss trading today. Along with the likes of Kite Pharma (Nasdaq: KITE) and Juno Therapeutics (Nasdaq: JUNO), Novartis is leading the way in the emerging field of CAR-T investigational therapies.