BMS and AbbVie get FDA lift
pharmafile | May 21, 2014 | News story | Research and Development, Sales and Marketing | AbbVie, BMS, FDA, elotuzumab, multiple, myeloma
Bristol-Myers Squibb and AbbVie are celebrating after receiving breakthrough designation status from the US regulator for their investigational medicine elotuzumab in multiple myeloma.
The Food and Drug Administration’s decision is a significant boost for the companies, which are developing the cancer antibody together, with BMS leading on commercialisation activities.
The FDA edict – which could speed up the product’s development – covers elotuzumab in combination with lenalidomide and dexamethasone for treatment of multiple myeloma in patients who have received one or more prior therapies.
The disease is a progressive haematologic cancer that comes from bone marrow and remains incurable, with a five-year survival rate of 44.9 per cent.
Around 750,000 people are living with myeloma worldwide, and the FDA clearly sees the drug as potentially important in combating this life-threating condition, a decision based on Phase II study data presented at the Annual Congress of the European Hematology Association last year.
The trial looked at two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients – including a 10 mg/kg dose now being studied in Phase III.
“Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need,” says Michael Giordano, BMS head of development, oncology & immunosciences.
“This breakthrough therapy designation underscores the potential of elotuzumab in this setting and reinforces BMS’s long-standing commitment to the research and development of novel medicines to treat hematologic malignancies,” he adds.
Elotuzumab is a humanised IgG1 monoclonal antibody targeted Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue.
Phase III trials in first-line multiple myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma (ELOQUENT-2) are underway.
BMS has another cancer antibody in late-stage development, nivolumab, a PD-1 inhibitor for melanoma, lung and kidney cancer, and a dozen or so other antibody candidates in early to mid-stage development.
Adam Hill
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