US FDA Reviewers Highlight Safety Concerns With GSK’s Investigational Cancer Drug: Retail’s On The Fence

U.S. Food and Drug Administration reviewers on Tuesday flagged certain concerns about GSK Plc’s (GSK) investigational cancer drug called Blenrep, including a high rate of ocular toxicities.

Ocular toxicity refers to the harmful effects a substance or drug has on the eye, potentially causing damage to its structure or impairing its function.

GSK is seeking approval for the drug, also known as Belantamab Mafodotin, in the treatment of adults with multiple myeloma in combination with Bortezomib or Pomalidomide and Dexamethasone in patients who have received at least one prior line of therapy. The application is based on data from two late-stage trials.

FDA reviewers stated in briefing documents on the regulator’s website that the benefit-risk profile of the drug for treating multiple myeloma “remains unclear,” considering efficacy results, safety and tolerability concerns, and uncertainties regarding the appropriateness of the proposed dosages.

The documents were released ahead of an advisory committee meeting scheduled for Thursday. The FDA is expected to decide on approving or disapproving the drug by next week.

The reviewers noted a high incidence of ocular toxicity with the treatment, including keratopathy (changes in the corneal epithelium), changes in clarity of vision, as well as other ocular symptoms, such as blurred vision and dry eyes.

“The ocular toxicity, including corneal toxicity, observed with Belantamab Mafodotin is a unique toxicity that is not seen with any currently available treatments for multiple myeloma,” they said.

While ocular toxicity may be asymptomatic in its early stages, it can result in severe consequences, such as loss of vision, the reviewers noted.

The agency also expressed concern that the dosages of Belantamab Mafodotin have not been adequately optimized, as evidenced by the high rates of dose modifications in both trials referred to in the application.

A majority of patients were not receiving the intended dosage and required frequent dose modifications, including interruptions, throughout the duration of treatment, the agency said.

Blenrep was previously granted accelerated approval as monotherapy on Aug. 5, 2020, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. It was subsequently withdrawn on Feb. 6, 2023, due to failure of the confirmatory trial to meet its progression-free survival endpoint.

On Stocktwits, retail sentiment about GSK fell from ‘bullish’ to ‘neutral’ territory over the past 24 hours while message volume remained at ‘high’ levels.

GSK stock is up 6% this year but down by 4% in the past 12 months.

Read Next: Joby Aviation Stock Flies High On Expansion Of Marina Site, Retail Boards The Flight

For updates and corrections, email newsroom[at]stocktwits[dot]com.