GSK blood cancer drug Blenrep faces USFDA scrutiny over vision issues

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-07-16T16:15:55+05:30 | Updated On 16 July 2025 4:15 PM IST

GSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised safety concerns on Tuesday that the drug, when used in combination with other treatments, may lead to eye damage in patients.

In the documents, posted on the health regulator's website, staff reviewers highlight that the benefit-risk profile of Blenrep remains unclear, citing issues about safety, tolerability, and appropriate dosing.

The agency noted incidents of ocular toxicity such as blurred vision, photophobia, and dry eye in patients receiving the combination therapies. Blenrep's initial approval already included a warning about ocular side effects.

According to Reuters, the assessment comes ahead of an independent expert panel meeting on Thursday. The FDA is set to decide on the drug next week.

The questions and briefing documents were less negative than feared, with no direct concerns raised about patient enrollment — a key investor worry — according to at least two analysts.

However, "the focus on dosing and benefit-risk indicates this will still be a tricky meeting (and potentially) launch", said Barclays analyst Emily Field. Shares of the company were volatile after the publication of the documents.

The panel will discuss if an appropriate dosage has been identified and will vote on the overall benefit-risk profile of the drug in combination with other treatments.

The ocular toxicity observed "is a unique toxicity not seen with any currently available treatments for multiple myeloma," staff reviewers said.

The agency noted that the dose adjustment protocols and ophthalmic monitoring schedules implemented in the trials may be difficult to reproduce in routine clinical practice, raising concerns about the drug's use outside tightly controlled study settings.

Blenrep belongs to a class of targeted cancer therapies called antibody drug conjugates that work like "guided missiles," killing tumor cells while leaving healthy ones unharmed.

The British drugmaker is seeking approval for Blenrep in combination with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for the treatment of patients with multiple myeloma who have received at least previous therapy.

Both bortezomib and pomalidomide are established cancer therapies, while dexamethasone is a widely used generic steroid drug

USFDAGSKGSK newsblenrepblood cancer drugblood cancerblurred visionphotophobiadry eye

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751