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 (FDA) Oncologic Drugs Advisory Committee voted that the risks from the drug, called Blenrep, outweighed its benefits. Panellists voted five to three against a combination of Blenrep and the generic cancer drug Velcade and seven to one against the drug in tandem with Pomalyst, marketed by Bristol Myers Squibb Co.

Glaxo’s American depositary receipts fell as much as 7.4% in New York.

The non-binding vote influences the FDA’s decision on whether to approve Blenrep.

Potential eye damage

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. A decision on the drug’s approval in the US is expected by 23 July.

The UK this year became the first country to authorise 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Blenrep was previously withdrawn in the US and Europe for use in a different group of patients, after it failed to prove it was better than existing treatments.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.

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