Besponsa beats CAR-T frontrunner to US market

In timely fashion, US pharma giant Pfizer (NYSE: PFE) has received US Food and Drug Administration (FDA) approval for Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Besponsa has made it to approval quickly, having only been granted priority review status by the FDA in February. It has also won the nod ahead of Swiss pharma giant Novartis’ (NOVN: VX) CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy which looks set to get FDA approval in this indication later this year, albeit for the pediatric and adult patient group.

Although Kite Pharma (Nasdaq: KITE) is also in the race, tisagenlecleucel-T, which Novartis is also evaluating for other indications, is likely to be the first of the new drug type to reach market, though it has still not beaten Besponsa to the final clearance.