US FDA approval tracker: March 2022

March proved to be a busy month at the FDA, with success for Novartis’s second radioligand product and the ushering in of three first-in-class drugs: Marinus’s Ztalmy, CTI Biopharma’s Vonjo, and Bristol Myers Squibb's Opdualag. The final product on the list is a combination of Opdivo and relatlimab, the first Lag3 inhibitor to pass the regulator. Bristol might be hoping that relatlimab’s reduced toxicity will allow it in time to swap out Yervoy in combination treatments. Meanwhile, approval of Novartis’s Pluvicto in patients with metastatic castration-resistant prostate cancer after androgen receptor blockade plus chemo looks to have provided some justification of the Swiss group’s $2.1bn acquisition of Endocyte in 2018. On the other side of the coin, those facing disappointment last month included Akebia, and Lilly and its Chinese partner Innovent. Akebia fell foul of FDA concerns around thromboembolic events and toxicity, which have hit others in the HIF-PH inhibitor space, while Lilly/Innovent’s chances of approval for the PD-1 antibody Tyvyt were doomed after a 14-1 advisory committee vote against.