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FDA Raises Alarms About Eye Safety in Blenrep Cancer Drug Combination
The U.S. Food and Drug Administration (FDA) has flagged serious eye safety concerns related to Blenrep (belantamab mafodotin), a blood cancer drug developed by GSK, especially when used in combination with other therapies for multiple myeloma. According to the agency, new data suggests the potential for unique ocular toxicity—including blurred vision, light sensitivity, and dry eye—that raises questions about the drug’s safety profile. These risks are now under formal review as GSK seeks broader approval for Blenrep alongside established cancer drugs like bortezomib, pomalidomide, and the steroid dexamethasone.
Blenrep was initially approved under the FDA’s accelerated approval program in 2020 based on early signs of efficacy. However, serious concerns have remained about eye damage. With new trial results now under consideration, the agency is scrutinizing not only whether Blenrep is effective but whether the benefit outweighs the risk—particularly for eye-related side effects that may not be manageable in normal healthcare settings.
What Is Blenrep and How Is It Supposed to Work?
Blenrep is part of a newer class of drugs called antibody-drug conjugates (ADCs). These targeted therapies are designed to attach to cancer cells and deliver toxic agents directly to the tumor, ideally sparing healthy tissue. The drug specifically targets BCMA (B-cell maturation antigen), a protein found on myeloma cells. Once attached, the drug releases a chemical that kills the cancer cells.
When it works as intended, Blenrep offers a more targeted alternative to traditional chemotherapy. But the effectiveness of the treatment does not erase the drug’s risk profile. A number of patients in trials have experienced moderate to severe ocular toxicity. These effects are considered serious because they may lead to lasting vision damage.
FDA Concerned About Reproducibility of Safety Measures
A major concern raised by FDA reviewers involves how eye health was monitored during clinical trials. In tightly controlled studies, patients underwent routine eye exams and dosage adjustments based on the severity of side effects. However, the FDA notes that such careful protocols may not be feasible in general clinical settings.
In real-world medical practice, not all oncology clinics have immediate access to eye specialists or the capacity to conduct regular vision assessments. This makes it difficult to manage side effects consistently, potentially exposing more patients to preventable vision damage. Additionally, questions remain about whether GSK has established a universally safe dosage for Blenrep in combination with other drugs.
Ocular Toxicity: What Are the Risks to Patients?
FDA reviewers describe the vision issues associated with Blenrep as a “unique toxicity” not seen with other treatments for multiple myeloma. The ocular complications reported include:
These conditions are not only painful and disruptive but can also lead to long-term or permanent impairment. Some patients may require corrective surgery or prolonged medical treatment. The inability to predict which patients will develop eye damage makes these side effects even more concerning.
Although patients enrolled in the trials had access to comprehensive eye care, individuals receiving the drug in everyday practice may not have the same support, leading to delayed recognition and treatment of side effects.
Legal Liability and Patient Rights: When a Drug Causes Harm
When a drug poses known risks that are not adequately disclosed or mitigated, affected patients may be entitled to financial compensation. Drug manufacturers are responsible for conducting thorough safety testing, communicating all known side effects, and ensuring that medical professionals can reasonably manage risks in normal practice settings.
If GSK failed to ensure that Blenrep’s safety protocols could be reproduced outside of a clinical trial environment, or if they pushed for approval without full disclosure of long-term eye risks, they could face liability in future lawsuits.
Potential legal claims may include:
Patients who have experienced permanent or severe eye injuries after being treated with Blenrep should consider a legal review of their case.
What Patients Should Do If They Experience Eye Problems After Blenrep
If you or a loved one is being treated with Blenrep and you begin experiencing vision problems, it is essential to take the following steps:
Acting quickly can improve your chances of identifying the cause of your symptoms and strengthening any legal claim you may have.
If you have suffered eye injuries after being treated with Blenrep for multiple myeloma, you may be entitled to financial compensation. Parker Waichman LLP is a national personal injury law firm that handles pharmaceutical injury claims and is currently reviewing cases related to Blenrep. Our legal team is ready to assess your case at no cost.
Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation today. You may have a limited time to file a claim, so don’t delay. Regardless of your location or where your injury occurred, our nationwide product injury law firmis ready to assist you and discuss your claim for free.
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