Drugs

GSK’s Blenrep Approved for Market Reintroduction

FDA has approved a GSK BLA for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib (Velcade) and dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. The BLA also sought approval for Blenrep in combination with pomalidomide (Pomalyst) and dexamethasone, but that indication did not receive approval.

The agency action now allows the drug to be reintroduced in the U.S. Blenrep was originally granted accelerated approval in 2020 for heavily pretreated multiple myeloma patients. In 2022, its approval was withdrawn after the DREAMM-3 trial, designed to confirm the drug’s benefit, did not demonstrate superiority over standard treatment.

The BLA saw a review extension in July following an Oncologic Drugs Advisory Committee meeting that voted against approving the submission. Panel members voted five to three against the risk-benefit profile on the proposed dosage of Blenrep in combination with bortezomib and dexamethasone; and seven to one against the risk-benefit profile on the proposed dosage of Blenrep in combination with pomalidomide (Pomalyst) and dexamethasone. Panel members seemed to agree with concerns raised in an FDA briefing document )that highlighted a persistent and troubling safety signal — ocular toxicity (see earlier story).

GSK says the approval is based on data from the pivotal DREAMM-7 Phase 3 trial. In patients who had two or more prior lines of therapy, including a PI and an IMID, the Blenrep combination demonstrated a clinically meaningful 51% reduction in the risk of death, and a median progression-free survival of 31.3 months versus 10.4 months for the combination of daratumumab, bortezomib and dexamethasone.

“Working closely with the FDA,” GSK says, “Blenrep is available through a new, streamlined Risk Evaluation and Mitigation Strategy (REMS). The new REMS supports appropriate use and patient safety while reducing administrative burden through simplified patient forms, removal of duplicative checklists and efficient communication between HCPs [healthcare providers] and either optometrists or ophthalmologists monitoring eye care.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome