GSK's blood cancer drug fails to secure US FDA advisers' support
GSK has sought approval to re-launch Blenrep in combination with other treatments for patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
The drug was withdrawn from the U.S. market in 2022 after failing to show it was better than an existing treatment in a late-stage study.
GSK's U.S.-listed shares fell nearly 6% after the panel voted 5-3 to say the benefits of Blenrep with bortezomib and dexamethasone at the proposed dosage did not outweigh its risks.
The panel also voted 7-1 against Blenrep in combination with pomalidomide and dexamethasone.
The company did not immediately respond to a request for comment.
Bortezomib and pomalidomide are approved cancer therapies, while dexamethasone is a widely used generic steroid drug.
The FDA is expected to make a formal approval decision next week and typically follows the advice of its expert advisers, but is not required to do so.
UK's drug regulator had approved the Blenrep combination treatments in April.
The FDA advisers' vote comes after the agency's staff reviewers raised concerns about Blenrep on Tuesday, especially incidents of ocular toxicity such as blurred vision, photophobia, and dry eye.
Even when Blenrep was approved in the U.S., it carried a warning for eye-related side effects.
During Thursday's panel discussion, members also raised concerns around its dosing regimen and lack of U.S. patient representation in the trials.
"It is really disappointing to see the fact that we're still allowing drugs to gain approval with less than 5% US enrollment," said panelist Daniel Spratt, who is also associate chief scientific officer at University Hospitals Cleveland Medical Center.
Blenrep is an antibody-drug conjugate, a type of drug that destroys tumor cells while sparing healthy ones.
GSK's new application was based on results from two late-stage trials in which the combinations helped reduce the risk of death and delay cancer progression.
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