US FDA approval tracker: April 2021

Last month was loaded with US FDA knockbacks and delays. Reviews of four Jak inhibitors – abrocitinib, Xeljanz, Olumiant and Rinvoq – were pushed back until the third quarter, apparently on ongoing toxicity concerns with the class. Manufacturing inspection issues also rumbled on, resulting in a delay for Sol-Gel’s rosacea cream Epsolay and a CRL for Protalix’s Fabry candidate pegunigalsidase alfa. Meanwhile, the FDA’s adcom on accelerated approvals for anti-PD-(L)1 drugs gave positive votes for four of six indications discussed. The panel pushed back against Keytruda’s use in late-line gastric cancer and Opdivo’s in second-line liver cancer. Separately, Glaxosmithkline’s own anti-PD-L1 MAb Jemperli finally gained accelerated approved in second-line mismatch repair-deficient endometrial cancer, after a five-month delay caused by Covid-19 travel restrictions.