The pharma­ceu­tical com­pa­nies Bristol-Myers Squibb and AbbVie an­nounced this morn­ing that the U.S. Food and Drug Admin­istra­tion has granted break­through ther­apy desig­na­tion to the inves­ti­ga­tional drug elo­tuz­u­mab ^[1].

Specifically, the Food and Drug Admin­istra­tion (FDA) granted break­through ther­a­py desig­na­tion to elotuzumab in com­bi­na­tion with Revlimid ^[2] (lena­lido­mide) and dexamethasone ^[3] (Decadron) for mul­ti­ple myeloma patients who have re­ceived one or more prior ther­a­pies.

The break­­through ther­apy desig­na­tion is a new desig­na­tion that was signed into law in 2012. It is de­signed to ac­cel­er­ate the de­vel­op­ment and review process for drugs in­tended to treat serious or life-threatening ill­nesses.

Elotuzumab is now the sec­ond po­ten­tial new myeloma treat­ment that has re­ceived the break­­through ther­a­py desig­na­tion.  Daratumumab ^[4] re­ceived the desig­na­tion in May of last year (see re­lated Beacon ^[5] news).

Currently, The Beacon esti­mates that elotuzumab could be approved by the FDA and launched in the U.S. as a new treat­ment for mul­ti­ple myeloma by late 2015 or early 2016. Approval in Europe is likely to follow shortly there­after. Launches in spe­cif­ic Euro­pean countries would then oc­cur through­out the rest of 2016.

These pro­jec­tions are based on data provided to The Beacon by Evaluate Ltd., a mar­ket intelligence and analysis firm, and on dis­cus­sions with fi­nan­cial analysts at Inter­na­tional Strategy & Investment (ISI) and Sanford C Bernstein & Co.

Elotuzumab is being devel­oped by Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE:ABBV).  It belongs to a class of drugs called mono­clonal anti­bodies, which work by identifying pro­teins on the surface of cancer cells and signaling for the im­mune sys­tem to destroy the cells.

In the case of elotuzumab, a pro­tein known as CS1 is targeted by the drug.  CS1 is commonly found on the surface of myeloma cells.  In the case of dara­tu­mu­mab, SAR650984 ^[6], and MOR202 ^[7] – which also are mono­clon­al anti­bodies being devel­oped as po­ten­tial myeloma ther­a­pies – a pro­tein known as CD38 is targeted by the drugs.

The break­­through ther­apy desig­na­tion for elotuzumab is based on findings from a Phase 2 study that assessed elotuzumab in com­bi­na­tion with Revlimid and low-dose dexa­meth­a­sone for the treat­ment of mul­ti­ple myeloma patients who have re­ceived one or more prior ther­a­pies.

Results of that trial showed that elotuzumab in com­bi­na­tion with Revlimid and low-dose dexa­meth­a­sone dem­onstrates sub­stan­tial re­sponse rates and fa­vor­able pro­gres­sion-free sur­vival in this patient pop­u­la­tion (see re­lated Beacon ^[8] news).

One of the doses tested in that trial (10 mg/kg) is cur­rently being in­ves­ti­gated in Phase 3 trials.

For more in­for­ma­tion about elotuzumab's break­­through ther­apy desig­na­tion, please see the re­lated press re­lease issued by BMS and AbbVie ^[9].

Note: This article was up­dated on Wednesday, May 21, to in­cor­po­rate revised pro­jec­tions of elotuzumab's U.S. and Euro­pean ap­prov­al and launch dates.