By Bhanvi Satija LONDON (Reuters) -GSK’s London-listed shares fell about 2% on Friday after the U.S. Food and Drug Administration approved only one of two treatment combinations with the British firm’s blood cancer drug, limiting the scope of its return to the U.S. market. The drug, Blenrep, which was pulled from the United States in […]
Health
GSK shares fall as narrow approval of blood cancer drug limits US relaunch
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By Bhanvi Satija
LONDON (Reuters) -GSK’s London-listed shares fell about 2% on Friday after the U.S. Food and Drug Administration approved only one of two treatment combinations with the British firm’s blood cancer drug, limiting the scope of its return to the U.S. market.
The drug, Blenrep, which was pulled from the United States in 2022, was approved in combination with cancer therapy bortezomib and dexamethasone steroid for patients who have been previously treated at least twice.
GSK’s U.S. listed shares were trading 5% lower at $43.21 by 1548 GMT.
“We think overall this is an initially bounded U.S. re-entry,” Barclays analyst Shirley Chen wrote in a note.
GSK had also sought approval to treat less sick patients, or those who had only been treated once before, and it did not receive approval for another Blenrep regimen.
Investors are hoping that a U.S. relaunch will help GSK get closer to its ambitious peak sales projection of more than 3 billion pounds ($4.03 billion) for Blenrep.
Shore Capital analyst Sean Conroy said the latest approval reduces the U.S. commercial opportunity by about half.
Conroy expects Blenrep sales of 2 billion euros ($2.3 billion) by 2031, but will look to increase that forecast if the drug eventually receives the nod for use in less sick patients.
GSK is testing Blenrep combinations in multiple myeloma patients who have previously not been treated. It also expects to have follow-up data from patients treated only once before in 2028.
“There remains a path to advance Blenrep into an earlier treatment setting,” Conroy said.
Eye-related side effects could be a hurdle for the therapy, as they require specialist care and often force lower dosing, Barclays Chen said, adding that GSK’s efforts to simplify the FDA-requested safety program would be closely watched for progress.
Blenrep combinations are approved in the European Union, United Kingdom, Canada and other markets for patients who have been treated once before.
($1 = 0.7451 pounds)
($1 = 0.8575 euros)
(Reporting by Bhanvi Satija; Editing by Kirsten Donovan)