TSX gains after CPI shows US inflation rose 3%
Investing.com -- GSK’s anti-BCMA antibody drug conjugate Blenrep has received FDA approval to return to the US market, but with significant restrictions that may limit its commercial potential.
The approval is for Blenrep in combination with bortezomib and dexamethasone (BVd), known as the DREAMM-7 regimen, for adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
This approval comes despite a negative vote from the FDA’s Oncologic Drugs Advisory Committee (ODAC), which had determined that Blenrep regimens evaluated in the DREAMM-7 and DREAMM-8 studies did not have a favorable overall benefit risk at the proposed dose in the proposed patient population.
The FDA’s decision includes several key limitations. The drug is approved only for third-line multiple myeloma patients or later, rather than the second-line setting GSK had targeted. Only the DREAMM-7 regimen received approval, with the DREAMM-8 data not included in the label.
Additionally, Blenrep will be available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of ocular toxicity. The program requires prescribers to be certified and patients must undergo an ophthalmic exam from an optometrist or ophthalmologist before every dose, which is more restrictive than the UK label that limits eye exams to the first four doses.
The commercial impact of these restrictions could be substantial. In the US, there are approximately 27,000 second-line drug-treated multiple myeloma patients compared to about 11,000 third-line patients. Treatment durations are also typically shorter in third-line settings.
The DREAMM-7 regimen’s inclusion of the proteasome inhibitor Velcade (bortezomib) may present another challenge, as retreating multiple myeloma patients with a proteasome inhibitor is not always the preferred approach among community-based oncologists.
GSK currently forecasts peak sales for Blenrep of approximately $2 billion, accounting for 2.3% of the company’s net present value.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.