US FDA approval tracker: March 2021

Fibrogen and Astrazeneca had been gearing up for an approval decision on their chronic kidney disease project roxadustat last month, but a surprise advisory panel meeting is now in the works, at a date yet to be determined. Experts will play close attention to cardiac safety issues with the oral HIF-PH inhibitor. Akebia, which recently filed vadadustat, a similarly acting project with its own toxicity problems, will be watching the adcom with interest. Elsewhere, Keytruda got knocked back in neoadjuvant/adjuvant triple-negative breast cancer after a negative vote from an earlier panel meeting. Merck & Co will likely have to wait for data on event-free survival from the Keynote-522 study to get another shot here; these are due in the third quarter. Merck also voluntarily withdrew Keytruda's use in small-cell lung cancer. The anti-PD-1 antibody, alongside Roche's Tecentriq and Bristol's Opdivo, will be the subject of a panel towards the end of April looking at accelerated approvals for six indications in which confirmatory studies have failed (Go or no go? The FDA plays hardball, March 30, 2021).