GSK's Blenrep Makes Comeback in Multiple Myeloma Treatment Landscape
The U.S. Food and Drug Administration (FDA) has approved the return of GSK's antibody-drug conjugate Blenrep to the market, marking a significant turnaround for the once-withdrawn multiple myeloma treatment. The approval comes with a more limited label than initially anticipated, positioning Blenrep as a combination therapy for patients who have received at least two prior lines of treatment.
FDA Approval and New Indication
Blenrep (belantamab mafodotin) has been approved in combination with bortezomib (Velcade) and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma who have undergone at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. This approval is based on results from the Phase III DREAMM-7 study, which demonstrated significant improvements in progression-free survival and overall survival compared to a daratumumab-based regimen.
Tony Wood, GSK's Chief Scientific Officer, stated, "There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes." Wood emphasized Blenrep's unique position as the only anti-BCMA agent that can be administered across various healthcare settings, including community centers where 70% of multiple myeloma patients receive care.
Clinical Data and Safety Considerations
The DREAMM-7 trial showed that the Blenrep combination reduced the risk of death by 51% and tripled median progression-free survival to 31.3 months, compared to 10.4 months for the control arm. Despite these positive results, the FDA's approval comes with considerations regarding ocular toxicity, a known side effect of Blenrep.
To address safety concerns, GSK has worked with the FDA to implement a "streamlined" Risk Evaluation and Mitigation Strategy (REMS). This includes simplified patient forms and improved communication between doctors and eye care specialists to support patient safety.
Market Implications and Competition
Blenrep's return to the U.S. market occurs in a landscape that has evolved since its initial withdrawal in 2022. The drug will face competition from established treatments like Johnson & Johnson's Darzalex, as well as emerging therapies such as CAR-T cell treatments. Despite these challenges, GSK remains optimistic about Blenrep's potential, with previous peak sales estimates exceeding £3 billion (approximately $4 billion), although this projection was based on a second-line treatment indication.
The pharmaceutical giant views Blenrep as a "material growth driver" for the coming years, highlighting its accessibility advantage in community-based care settings. As the multiple myeloma treatment paradigm continues to evolve, Blenrep's unique profile and administration flexibility may provide GSK with a competitive edge in this challenging therapeutic area.
References
- GSK’s Blenrep Makes Comeback With FDA Nod for Third-Line Multiple Myeloma
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
- FDA clears return of GSK’s once-withdrawn multiple myeloma drug
The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market only two years later.
- GSK's once-withdrawn Blenrep gets 2nd wind in US with FDA nod to treat certain myeloma patients
After a negative advisory committee vote and a postponed approval decision, the FDA opted to approve GSK's Blenrep in one of its two proposed combinations.
Explore Further
What are the specific ocular toxicities associated with Blenrep, and how does the streamlined REMS address these concerns?
What were the key findings of the Phase III DREAMM-7 study that led to Blenrep's approval as a combination therapy?
How does Blenrep compare to Johnson & Johnson's Darzalex and emerging CAR-T cell treatments in terms of efficacy and market positioning?
What are the anticipated challenges for Blenrep in navigating the competitive multiple myeloma treatment landscape since its re-entry into the market?
How does Blenrep's ability to be administered in community-based healthcare settings offer an advantage over other BCMA-targeting agents?