GSK kicks off Blenrep's market return with first myeloma combo nod in UK

 GSK has secured the first regulatory approval for Blenrep since the antibody-drug conjugate’s global market withdrawal in 2022.

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has become the first to sign off on Blenrep as part of two different combinations for treating multiple myeloma patients who have received at least one prior therapy, GSK said Thursday.

The approval allows the BCMA-targeted therapy to be used with either Takeda’s Velcade (bortezomib) or Bristol Myers Squibb’s Pomalyst (pomalidomide), plus dexamethasone in second-line myeloma treatment.

This world-first approval marks a milestone in GSK’s plan for Blenrep to reach peak annual sales of more than 3 billion pounds sterling (about $4 billion). Blenrep’s potential global reentry also gave GSK confidence to boost its 2031 sales target to more than 40 billion pounds despite uncertainties around the company’s flagship vaccines business.

A regulatory approval further redeems Blenrep’s reputation following its previous market withdrawal triggered by a phase 3 monotherapy flop in third-line multiple myeloma.

“As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse,” Hesham Abdullah, M.D., GSK’s global head of oncology R&D, said in a statement Thursday.

Despite its history as a monotherapy, Blenrep proved its worth in two combo trials.

In DREAMM-7, Blenrep beat Johnson & Johnson’s Darzalex in their respective pairings with Velcade and dexamethasone (Vd). Blenrep-Vd slashed the risk of progression or death by 59% versus Darzalex-Vd. The GSK regimen also helped patients live longer, lowering the risk of death by 42% versus the Darzalex-based comparator.

In DREAMM-8, Blenrep’s combination with Pomalyst and dexamethasone (Pd) has shown a 48% reduction in the risk of progression or death versus Velcade-Pd

Besides the U.K., Blenrep combinations are currently under review in 14 territories, according to GSK. In the U.S., the FDA is slated to deliver a verdict by July 23 this year.

Blenrep will need to compete with J&J and Legend Biotech’s powerful CAR-T therapy Carvykti on the global market—although not in the U.K. just yet. Back in 2023, J&J shelved Caryvkti’s rollout in the U.K. as the company struggled to churn out enough supply to meet global demand. 

As an off-the-shelf therapy, Blenrep does boast a convenience edge over CAR-T therapy, which requires a complex production process using patients’ own T cells.

“As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival,” Joseph Mikhael, M.D., from City of Hope and chief medical officer of the International Myeloma Foundation, said in a statement Thursday.

https://www.fiercepharma.com/pharma/gsk-kicks-blenreps-market-return-first-myeloma-combo-nod-uk