Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.

The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.

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.

In this week's podcast edition of Five Must-Know Things: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up.