The questions and briefing documents were less negative than feared, with no direct concerns raised about patient enrollment — a key investor worry — according to at least two analysts.
However, "the focus on dosing and benefit-risk indicates this will still be a tricky meeting (and potentially) launch", said Barclays analyst Emily Field. Shares of the company were volatile after the publication of the documents.
The panel will discuss if an appropriate dosage has been identified and will vote on the overall benefit-risk profile of the drug in combination with other treatments.
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.
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.
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
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