Bristol-Myers Squibb, AbbVie's elotuzumab gains FDA breakthrough status for multiple myeloma

Bristol-Myers Squibb and AbbVie announced Monday that the FDA granted breakthrough therapy status to the experimental drug elotuzumab for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. Michael Giordano, head of development, oncology and immunosciences at Bristol-Myers Squibb, noted that the designation "underscores the potential of elotuzumab in this setting and reinforces [our] longstanding commitment to the research and development of novel medicines to treat haematologic malignancies."

The companies noted that the FDA's decision on the humanised monoclonal antibody, which targets SLAMF7, was based on data from a mid-stage study evaluating two dose levels of elotuzumab, including a 10 mg/kg dose currently being investigated in Phase III trials. Data from the Phase II study was most recently presented at the European Hematology Association congress in June last year.

Elotuzumab is being co-developed by Bristol-Myers Squibb and AbbVie, with the former leading the commercialisation of the therapy. The drugmakers noted that elotuzumab is currently being studied in Phase III trials in first-line multiple myeloma and relapsed or refractory multiple myeloma. In addition, a Phase II study is assessing the therapy in combination with bortezomib and dexamethasone for relapsed or refractory multiple myeloma, while the compound is also being developed as a monotherapy for smouldering myeloma.

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