Clinical GSK to Pull Blood Cancer Drug Blenrep From U.S...

GSK to Pull Blood Cancer Drug Blenrep From U.S After Failed Trial


GSK has announced that Blenrep, a drug that the company developed to treat blood cancer, will no longer be available for purchase in the United States. This is the most recent failure for the oncology division of the British pharmaceutical giant.

The FDA requested that the company withdraw Blenrep’s (belantamab mafodotin) marketing authorization, and the company said it has begun the necessary steps to do so. 

Patients currently enrolled in Blenrep’s Risk Evaluation and Mitigation Strategy (REMS) will be offered the opportunity to enroll in a compassionate use program so that they may continue to have access to treatment. Prescribers who have opted in to receive updates from the REMS will receive additional details on how to enroll patients in the program. The company has advised its patients to reach out to their healthcare provider regarding this.

As an antibody drug conjugate, Blenrep is designed to attach to tumor cells and then release chemicals that destroy the cells. Following its approval in 2020, it was expected to be a game-changer for GSK in the treatment of patients with multiple myeloma who had previously been treated with at least four earlier therapies, including an anti-CD38 monoclonal antibody.

That accelerated approval was contingent on a confirmatory study to ensure that Blenrep’s safety and effectiveness held up in a trial conducted on a bigger scale. However, when the primary findings of the DREAMM-3 study were published earlier this month, the status of the BCMA-targeted antibody-drug conjugate (ADC) was in danger.

Patients who had previously received at least two rounds of proteasome inhibitor therapy and  lenalidomide did not benefit from the use of Blenrep when compared to standard therapy using pomalidomide. This spelled unfortunate news for GSK.

Based on all of the information gathered during the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) development program, GSK maintains its position that Blenrep continues to have a favorable benefit-risk profile in this challenging-to-treat RRMM patient population. Patients who responded to the drug had long-lasting clinical benefits, and safety stayed in line with what was already known.

Sabine Luik, GSK’s chief medical officer, said, “We respect the agency’s approach to the accelerated approval regulations and associated process. Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments. We will continue the DREAMM clinical trial program and work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”

GSK has previously announced its plans to turn Blenrep into a £3 billion drug. Despite being the first drug to specifically target BCMA, sales have been slow thus far, totaling only a modest £36 million in the third quarter. Currently, Benlap is pinning its hopes on two additional clinical trials, DREAMM-7 and 8, both of which are progressing as planned and are expected to report their findings in the first half of 2023.

Although oncology has long been GSK’s primary focus as a standalone prescription pharmaceutical company, the company took a major blow this month when it was told to limit access to its Zejula treatment for ovarian cancer in the U.S.

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