The US Food and Drug Administration has granted breakthrough therapy designation to Bristol-Myers Squibb and AbbVie’s elotuzumab for multiple myeloma.
The status has been granted specifically for use of elotuzumab in combination with lenalidomide and dexamethasone for MM patients who have received one or more prior therapies. The designation is based on a Phase II study presented at last year’s European Haematology Association meeting which showed that the triple combo offered a signifiant benefit in progression-free survival (33 months).
Breakthrough designation differs from the FDA’s other fast-track programmes as it involves more intensive guidance from the agency on putting together an efficient drug development programme. The criteria require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Michael Giordano, head of oncology and immunosciences development at B-MS, said that “despite recent advances in the treatment of relapsed or refractory MM, it remains an area of unmet need”. He added that getting breakthrough status “underscores the potential of elotuzumab in this setting”.
The news comes days after the FDA granted B-MS’ investigational PD-1 immune checkpoint inhibitor nivolumab breakthrough designation for patients with Hodgkin lymphoma after failure of autologous stem cell transplant and Seattle Genetics’ Adcetris (brentuximab).
Clovis NSCLC drug also gets breakthrough
The FDA has also granted breakthrough designation to Clovis Oncology’s CO-1686 as monotherapy for the treatment of second-line EGFR mutant non-small cell lung in patients with the T790M mutation.
The status has been granted based on interim efficacy and safety results from an ongoing Phase I/II study. Chief executive Patrick Mahaffy said the designation “is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application by mid-2015”.
