Bristol-Myers Squibb gains 'breakthough therapy' designation for cancer drug
- 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.
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.