Shares of UK-listed GSK Plc fell as much as 6.5% on Friday, July 18, after its key blood cancer drug, failed to secure the backing of a panel of US regulatory advisers.This has now put the potential of the drug getting approved in jeopardy.
According to reports, the USFDA’s Oncologic Advisory Committee voted that the risks from the drug, called Blenrep, outweighed its benefits. Panelists voted 5-to-3 against a combination of Blenrep and he generic cancer drug Velcade, and 7-to-1 against its use in tandem with Pomalyst, which is marketed by Bristol Myers Squibb.
Although this vote is non-binding, it can influence whether regulators approve the drug. The approval is expected by next week, July 23.
The committee’s advisors highlighted concerns with dosing and the associated toxicity. There have been concerns that Blenrep my harm the eyes and for questions about whether lower dose might reduce the risk.In a statement post the developments, GSK said that it remains confident in Blenrep’s safety and efficacy and will work with the USFDA, as it reviews the drug.
According to reports, the USFDA’s Oncologic Advisory Committee voted that the risks from the drug, called Blenrep, outweighed its benefits. Panelists voted 5-to-3 against a combination of Blenrep and he generic cancer drug Velcade, and 7-to-1 against its use in tandem with Pomalyst, which is marketed by Bristol Myers Squibb.
Although this vote is non-binding, it can influence whether regulators approve the drug. The approval is expected by next week, July 23.
The committee’s advisors highlighted concerns with dosing and the associated toxicity. There have been concerns that Blenrep my harm the eyes and for questions about whether lower dose might reduce the risk.In a statement post the developments, GSK said that it remains confident in Blenrep’s safety and efficacy and will work with the USFDA, as it reviews the drug.
Blenrep was first authorised in the UK this year, in combination with other oncology drugs. A formal approval from the European Medicines Agency is also expected later this year.
Blenrep was previously withdrawn in the US and Europe for use in a different group of patients, after it failed to prove it was better than existing treatments.
Shares of GSK Plc are trading 6.4% lower on Friday at 1,321.26.
(With Inputs From Agencies.)
