Dive Brief:
- FDA has designated elotuzumab as a ‘breakthrough therapy’ for the treatment of multiple myeloma.
- BMS has invested hundreds of millions of dollars in the therapy since 2008, starting with a $30 million in-licensing fee to PDL Biopharm.
- This is the second ‘breakthrough therapy’ designation the company has received this month.
Dive Insight:
In 2013, the FDA started designating certain promising drugs as "breakthrough therapies." This designation is for drugs that address an unmet medical need for a disease with a high level of mortality, or represent a significant improvement over current standard of care. Many of the drugs that have received breakthrough therapy status are for the treatment of cancer. Since 2013, a total of 30 drugs have received ‘Breakthrough Therapy’ designation, while 23 applications have been denied.
Based on phase 3 clinical trials, when combined with adjuvant treatment agents, elotuzumab 10 mg increased progression-free survival in patients with multiple myeloma by 33 months. Though there is some controversy surrounding the process of fast-tracking drugs by giving them a breakthrough therapy designation, there is strong support within FDA, as well as a consensus that more effective treatment options for cancer are always welcome.