Bristol-Myers Squibb ($BMY) has won its second breakthrough therapy designation from the FDA inside a week. Just days after getting the FDA's elite status for its closely watched anti-PD-1 drug nivolumab, the agency has followed up with a nod for elotuzumab, an experimental multiple myeloma therapy partnered with AbbVie and now in Phase III.
Elotuzumab is an anti-CS1 antibody, binding to the CS1 glycoprotein found on myeloma cells and "natural killer" cells in a way that focuses the immune system on killing myeloma cells while leaving healthy cells alone.
Last summer investigators reported that a 10 mg dose of elotuzumab in combination with lenalidomide and low-dose dexamethasone, which is being used in the Phase III program, registered a median progression-free survival rate of 33 months.
The breakthrough designation is an endorsement of Bristol-Myers' decision back in 2008 to in-license elotuzumab from PDL BioPharma for $30 million upfront and hundreds of millions in milestones. Months later PDL spun off its biotech work into Facet, which was snapped up by Abbott ($ABT) in 2010 for $450 million. And now those rights are held by Abbott spinoff AbbVie ($ABBV), which finds itself partnered with Bristol, which is leading the way on the development work.
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| FDA Oncology Chief Richard Pazdur |
The significance of a breakthrough drug designation and the open-door commitment the agency makes to these drugs has been hotly debated in biotech circles since the FDA first started handing them out at the beginning of 2013. The biggest impact, though, has become readily apparent in oncology, where FDA cancer czar Richard Pazdur has been a strong advocate for cutting short research timelines on the most promising new drugs in the pipeline. That commitment has been a significant boost for the giant companies in the field, which dominate cancer drug research globally.
"Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need," said Michael Giordano, the head of development on oncology and immunosciences at Bristol-Myers Squibb. "This Breakthrough Therapy Designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb's longstanding commitment to the research and development of novel medicines to treat hematologic malignancies."
- here's the release