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FDA green lights BMS’ multiple myeloma combo

Speedy approval follows a breakthrough designation


Bristol-Myers Squibb and AbbVie have gained a rapid FDA approval to broaden the use of multiple myeloma treatment Empliciti as part of new combined treatment regimen.

Empliciti was initially approved back in 2015 to treat refractory/relapsing multiple myeloma patients who have received between one and three prior treatments as part of a triple combination treatment.

That particular regimen also includes corticosteroid medication dexamethasone and Celgene’s blockbuster Revlimid, which generated around $8bn in sales last year.

Now, after a breakthrough designation, BMS has gained approval of Empliciti as part of a new combination known as EPd.

This comprises another Celgene product Pomalyst, along with dexamethasone, and has delivered some robust results.

A recent phase 2 study, ELOQUENT-3, tested the combination in multiple myeloma patients who received two or more prior therapies, and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor.

The results showed the combination could cut the risk of myeloma progression by 46% compared to Pomalyst and dexamethasone alone (Pd) This also demonstrated that the combination achieved an overall response rate of 53.3%, compared to 26.3% in those receiving Pd alone.

The US regulator approved the new regimen to treat this particular subset of multiple myeloma patients.

Joseph Eid

BMS' Joseph Eid

“Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,” said Joseph Eid, senior vice president and head of Medical, Bristol-Myers Squibb.

“[The] approval reinforces the importance of Immuno-Oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients.”

However, Johnson & Johnson’s Darzalex, which was approved around the same time as Empliciti, is streaking into the lead among a slew of next generation myeloma treatments.

Darzalex has picked up a number of indications, including a very significant first-line use in multiple myeloma patients who aren’t eligible for transplant.

J&J's drug is already in blockbuster territory: it has just recorded third quarter sales of $498 million, this compares to Empliciti, which managed to bring in a much more modest $59m in sales for BMS in the period.

Article by
Gemma Jones

9th November 2018

From: Regulatory



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