The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing.
The agency is meeting with its Oncologic Drugs Advisory Committee July 17 to discuss whether the drug’s proposed doses are appropriate given the high rates of ocular toxicity seen in the clinical trials, according to a briefing document. The studies tested Blenrep in combination with standard therapies for relapsed or refractory multiple myeloma.
Though Blenrep combinations improved progression-free survival for multiple myeloma patients, more than 75% of patients experienced severe eye toxicity, including blurred vision and corneal damage.
The panel will weigh whether revised dosing schedules could improve safety without compromising efficacy.
