GSK (GSK) stock crumbled Friday after the Food and Drug Administration granted its blood cancer treatment, Blenrep, a narrower-than-expected approval.
The agency signed off on several combinations using Blenrep to treat multiple myeloma patients who’ve undergone at least three prior lines of therapy.
GSK was gunning for a comeback with Blenrep, which won accelerated approval in 2020. But the drug failed its confirmatory study and GSK pulled it from the market in 2022. The company was aiming for an approval in second-line treatment, meaning patients only need to have worsened while taking one prior drug before trying Blenrep.
In late morning trading on today’s stock market, GSK stock toppled more than 5% to 43.19.
GSK Stock: Rivaling J&J’s Darzalex
To win approval, GSK pitted Blenrep against Johnson & Johnson‘s (JNJ) multiple myelomas treatment Darzalex.
In the study, DREAMM-7, the Blenrep-based regimen showed a significant improvement vs. its rival in overall survival and progression-free survival. Overall survival is how long patients live before dying of any cause, while progression-free survival is the length of time before cancer worsens.
But, ahead of the approval, a panel of FDA advisors noted Blenrep recipients often experienced ocular side effects, including ulcers on their corneas and a decline in visual acuity, including severe vision loss. The advisory committee later voted that the benefits of Blenrep don’t outweigh its risks.
Still, GSK Chief Scientific Officer Tony Wood called the approval Friday a “significant milestone.”
“There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse, and re-treating with the same mechanism of action often leads to suboptimal outcomes,” he said in a written statement.
He noted Blenrep is the only drug in its class that can be administered across health care settings, including in community centers where 70% of patients receive their care.
“Blenrep fulfills a major patient need,” he said.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
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