At ASH, GSK’s Top Cancer Exec Discusses the FDA’s Different Take on Multiple Myeloma Drug Blenrep

Comeback stories are often the stuff of movies, but GSK is showing they can also happen in pharmaceuticals. The multiple myeloma medicine Blenrep has returned to the market three years after GSK voluntarily withdrew the product following the failure of the confirmatory study required of its accelerated FDA approval.

But drug approvals, like movie comebacks, have limits. GSK submitted the same new Blenrep clinical trial data to all drugs agencies, but did not get quite the same regulatory outcome in the U.S. While regulators in Europe and elsewhere approved Blenrep for use as a second-line multiple myeloma therapy, the new FDA approval permits the drug only as a third-line or later treatment for this blood cancer . In this setting, GSK is competing for market share against CAR T therapi