The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.

The group’s new muscular dystrophy pill seems unlikely to cut into Sarepta’s sales.