GSK Blood Cancer Drug Blenrep Fails To Win FDA Panel Support

GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

The US Food and Drug Administration’s Oncologic Drugs 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 the generic cancer drug Velcade and 7-to-1 against its use in tandem with Pomalyst, marketed by Bristol Myers Squibb Co.

Glaxo’s American depositary receipts fell 4.7% in New York.

The non-binding vote influences whether the FDA will approve Blenrep, a decision that’s expected by July 23.

GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said in a statement.

The meeting had been closely watched because of concerns that Blenrep potentially may harm the eyes, and questions about whether a lower dose might reduce the risk.

The UK this year became the first country to authorize Blenrep, in combination with other oncology drugs. That was for some patients with multiple myeloma — an incurable blood cancer — after they received one previous treatment.

Blenrep was previously withdrawn in the US and Europe for use in a different group of patients, after it failed to prove it was better than existing treatments.

GSK subsequently investigated Blenrep’s use in combination with other medicines and as an earlier line of treatment. It found it reduced the risk of death by 42% compared with a drug sold by Johnson & Johnson.