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2018-11-09| Trials & Approvals

Empliciti®(elotuzumab) combination – New IO approval for relapsed Multiple Myeloma

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By Ajay V. Patil

Empliciti®(elotuzumab)

Bristol-Myers Squibb (BMS) received regulatory approval from the U.S. FDA for the use of Empliciti (elotuzumab) in adults with multiple myeloma who have gone through at least two prior therapies. Elotuzumab is a humanized monoclonal antibody directed against surface antigen CD319. It is developed by BMS and AbbVie in collaboration but BMS is solely responsible for all commercial procedures.

ELOQUENT-3 phase II trial

Phase II trial (ELOQUENT-3) showed that, in relapsed or refractory multiple myeloma patients, Empliciti almost doubled both median progression-free survival and overall response rate in comparison to pomalidomide and dexamethasone. Empliciti, will serve as third line medication after this priority review approval in combination with pomalidomide and dexamethasone. Empliciti in combination with the EPd will also serve as an alternative for some popular treatments like lenalidomide (Revlimid by Celgene). Overall response rate, doubled in patients who received the triple combination EPd compared to patients who received pomalidomide and dexamethasone alone.

However, BMS reported some serious adverse reactions in, 22 percent of patients in EPd arm and in 15 percent of patients in pomalidomide and dexamethasone arm. Five percent of patients in the EPd arm, compared to 1.8 percent of patients in the control arm discontinued the treatment due to treatment related adverse effects. Taking this into consideration, FDA approval does come with precautions and warning information as stated by BMS.

Joseph Eid of BMS said, “Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the progression free survival of patient and this highlights importance of IO options in blood cancers”.

References

  1. https://www.biospace.com/article/bms-empliciti-garners-a-new-fda-indication-for-multiple-myeloma/
  2. https://news.bms.com/press-release/bristolmyers/us-food-and-drug-administration-approves-empliciti-elotuzumab-plus-pomali

Medtex

 

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