By Bhanvi Satija
LONDON (Reuters) -GSK’s London-listed shares fell nearly 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 U.S. market 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 5% lower at $43.51 in premarket trade.
“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.
Barclays said the narrow approval would restrict potential U.S. volumes.
Eye-related side effects are also a hurdle for the therapy, as they require specialist care and often force lower dosing. This could further limit how well the treatment works outside of clinical trials, Chen said.
Guggenheim analysts said that while the approval was encouraging, pricing and GSK’s plans to ease the risk evaluation and mitigation process for patients would be vital to boost investor confidence in Blenrep’s blockbuster potential.
GSK will also have to carve out its space in a crowded multiple myeloma market that includes cell therapies by Johnson & Johnson and Bristol Myers.
Blenrep combinations are approved in the European Union, United Kingdom, and other markets.
($1 = 0.7451 pounds)
(Reporting by Bhanvi Satija; Editing by Kirsten Donovan)
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