GSK Removes Blenrep From U.S. Market, Due Poor Clinical Trial Performance for Multiple Myeloma Drug

Blenrep failed to meet the goals of a confirmatory clinical trial required by the FDA to keep its accelerated approval license.

The blood cancer medication Blenrep will be removed from the market in the United States, following clinical trials that cast doubt on the effectiveness of the drug, according to an announcement this week by GlaxoSmithKline.

Blenrep (belanatamab mafodin-blmf) was given fast-track approval by the FDA in August 2022, for the treatment of relapsed/refractory multiple myeloma. The drug was approved based on early preliminary clinical trials, and was dependent upon further clinical trials to keep that approval.

On November 22, GlaxoSmithKline (GSK) issued a press release announcing it has begun the process of withdrawing Blenrep from the U.S. market, following disappointing Phase III clinical trial results, which did not show that Blenrep reached the efficacy requirements of the FDA’s Accelerated Approval program.

The clinical trial, known as DREAMM-3, was supposed to show Blenrep was better than existing treatments on the market, but failed to do so. But earlier this month, GSK indicated the confirmatory trial had failed to produce the results required by the agency.

However, GSK says it still has hopes for the drug, and clinical trials will continue. The company also indicated current Blenrep patients in the U.S. will have the option to continue receiving the drug, and other patients may enroll for access to it.

There are still two scheduled Phase III clinical trials expected to produce results in the first half of 2023, known ad DREAMM-7 and DREAMM-8. GSK will have to apply for a new biologics approval if those studies show Blenrep to be both safe and effective.

Blenrep is still approved for use in 17 other countries, most of those in Europe. The drug has already generated about $105 million in sales to date, with two-thirds of that being sold in the U.S.