Myeloma drug given Breakthrough Designation
Bristol-Myers Squibb and AbbVie’s new cancer treatment elotuzumab has been given a Breakthrough Therapy Designation by the FDA.
The companies are developing elotuzumab for combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in multiple myeloma patients who have received one or more prior therapies.
The last decade has seen significant progress in treatment of multiple myeloma, with Celgene’s Thalomid (thalidomide) and Revlimid and Janssen’s Velcade all helping to extent median survival times. These drugs are increasingly used as first line therapy, and this is translating into major revenues for the companies, with Celgene’s Revlimid expected to earn in excess of $4.5 billion this year.
However many patients relapse and stop responding to the Revlimid and dexamethasone combination, with few further treatment options available. BMS and AbbVie hope their drug can enter the market as a treatment for these patients.
Other players in the field include Onyx/Ono’s Kyprolis (carfilzomib), already on the market, and Takeda/Millennium’s late-stage MLN9708.
The new designation for elotozumab is based on a randomised Phase 2, open-label study that evaluated two dose levels of the drug in combination with Revlimid and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials.
The FDA’s Breakthrough Therapy Designation is aimed at speeding up the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require early clinical evidence that shows a drug may have “substantial improvement on at least one clinically significant endpoint over available therapy”.
“Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences, Bristol-Myers Squibb. He added that the Breakthrough Therapy Designation underscored the potential of elotuzumab and reinforced BMS’s Bristol-Myers Squibb’s commitment to the disease area.
Elotuzumab is a humanised IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue. The companies are investigating whether through both direct activation and engagement of Natural Killer cells, elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells.
The drug is being studied as a monotherapy in smouldering myeloma and in combination with other therapies in first-line and relapsed or refractory multiple myeloma. A clinical development programme for the agent is underway, including Phase 3 trials in first-line multiple myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma (ELOQUENT-2). Elotuzumab is also being investigated in a randomised Phase 2 study of bortezomib and dexamethasone in relapsed or refractory multiple myeloma.
AbbVie and BMS are co-developing the drug, with Bristol-Myers Squibb leading the commercialisation of the product.
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