Don’t call it a comeback. Blenrep’s been here for years. When GSK yanked its multiple myeloma drug from the U.S. market in 2022 for failing a confirmatory study, the company looked poised to get it back in the ring. 

But an FDA advisory committee voted against the antibody-drug conjugate yesterday, saying the benefits didn’t outweigh the risk. Briefing documents revealed earlier this week pointed to concerns over “ocular toxicities” that surfaced during two pivotal studies testing Blenrep in combination with other treatments. The agency could render its ultimate decision about the treatment, which GSK has pegged as a potential blockbuster growth-driver for the company, as early as next week. 

Safety issues can always sink a drug’s approval prospects. Last week, the FDA published 200 complete response letters for drugs that were later OK’d to offer “greater insight into the FDA’s decision-making and the most common deficiencies cited.” But the document release could also create legal problems for pharma. Today, we’re looking closer at the fallout from the agency’s latest move to boost “radical transparency” in healthcare regulations. 

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