FDA staff flags eye safety risks for GSK's blood cancer drug
In briefing documents released on the health regulator's website, staff reviewers said the benefit-risk profile of Blenrep remains unclear, citing concerns about safety, tolerability and appropriate dosages.
The British drugmaker is seeking approval for Blenrep in combination with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for the treatment of patients with multiple myeloma who have received at least previous therapy.
Both bortezomib and pomalidomide are established cancer therapies, while dexamethasone is a widely used generic steroid drug.
The assessment comes ahead of an independent expert panel meeting on Thursday. The FDA is set to decide on the drug next week.
The agency raised concerns of ocular toxicity such as blurred vision, photophobia, and dry eye in patients receiving the combination treatment. Blenrep's initial approval already carried a warning about ocular side effects.
The ocular toxicity observed "is a unique toxicity not seen with any currently available treatments for multiple myeloma," staff reviewers said.
The agency noted that the dose adjustment protocols and ophthalmic monitoring schedules implemented in the trials may be difficult to reproduce in routine clinical practice, raising concerns about the drug's use outside tightly controlled study settings.
The panel will discuss whether appropriate dosages have been identified for proposed patients and vote on whether the drug's overall benefit-risk profile in combination with other treatments is favorable.
Blenrep belongs to a class of targeted cancer therapies called antibody drug conjugates that work like "guided missiles," killing tumor cells while leaving healthy ones unharmed.
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