BMS, AbbVie get FDA OK for new myeloma regimen

Bristol-Myers Squibb and AbbVie have picked up another FDA approval for their multiple myeloma drug Empliciti that they hope will help drive uptake of the drug.

The US regulator has approved Empliciti (elotuzumab) in combination with Celgene’s Pomalyst (pomalidomide) and dexamethasone – a regimen known as EPd – for patients who’ve relapsed or don’t respond to at least two prior therapies, including Celgene’s older drug Revlimid (lenalidomide) and a proteasome inhibitor.

The green light comes just a few months after BMS and AbbVie reported the results of the phase 2 ELOQUENT-3 study that underpins Empliciti’s new approval and earned the EPd regimen a breakthrough designation from the FDA.

In the study – which was reported at the European Haematology Association (EHA) congress in Stockholm in June – patients receiving the triple therapy had a 46% lower risk of cancer progression than those on Pomalyst and dexamethasone alone. Median progression-free survival (PFS), the trial’s primary endpoint, was 10.3 months for those on EPd, compared with 4.7 months in those treated with Pomalyst and dexamethasone.

Empliciti was approved for use in combination with Revlimid and dexamethasone (ERd) in 2015, and was widely tipped as a future blockbuster with sales estimates from $1 to $3 billion, depending on the analyst asked. Since then growth has been sluggish, and it made just $178 million in the first nine months of the year, just $10 million more than the same period of 2017.

The product reached the market two weeks after Johnson & Johnson's Darzalex (daratumumab) became the first antibody therapy for multiple myeloma, and has struggled to find traction because there have been a slew of new therapies for the blood cancer.

At launch it was approved for second-line use while Darzalex was still only indicated for third-line use in ‘double refractory’ patients, which should have given it a key advantage in the marketplace. Since then however J&J has added to Darzalex’ label with a string of new indications, including second-line and most recently first-line use. As a result, the product has romped away, growing more than 50% to $1.4 billion in the first nine months of 2018.

The new approval is the label expansion for Empliciti and the first opportunity for BMS and AbbVie to try to extend the use of their drug, which actually saw sales decline year-on-year in the third quarter.

“Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,” said Paul Richardson, of the Dana-Farber Cancer Institute, the lead investigator in ELOQUENT-3.

“This new regimen … not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them,” he added. “To be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients.”