FDA Breakthrough Therapy Designation: #39 For Bristol-Myers Squibb
On May 14th, Bristol-Myers Squibb (BMS) announces that the FDA grants the Breakthrough Therapy Designation (BTD) to the company’s investigational PD-1 immune checkpoint inhibitor, Nivolumab. The BTD is for the treatment of Hodgkin Lymphoma (HL) after the failure of autologous stem cell transplant followed by Brentuximab. Nivolumab is part of a new class of cancer treatments know as immunotherapies. The BTD is based on data from an ongoing Phase 1b clinical trial.
This is the 39th BTD announced by a sponsor company, the 3rd BTD for BMS, and the 1st BTD for HL :
|1||3-Drug Regimen||Hepatitis C|
|2||Daclatasvir + Asunaprevir||Hepatitis C|
“Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. We are investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.”
BMS is currently studying Nivolumab as a monotherapy and in combination with other therapies, in more than 35 clinical trials for multiple tumor types :
• Non-Small Cell Lung Cancer (NSCLC)
• Renal Cell Carcinoma (RCC)
• Head & Neck Cancer
• Non-Hodgkin Lymphoma (NHL).
The FDA grants Fast Track designation for Nivolumab in :
Other BMS Announcements
BMS on May 14th, also makes several other announcements concerning Nivolumab :
• Clinical trial collaboration with Celldex Therapeutics to evaluate the combination of Nivolumab and Varlilumab for multiple tumor types
• Phase 1b study results that evaluates the safety and efficacy of Nivolumab (as a monotherapy) for patients with NSCLC who were previously treated (will be presented at the upcoming ASCO meeting)
• Phase 1b study results of Nivolumab (as a monotherapy) for patients with NSCLC in chemotherapy-naïve patients (will be presented at the upcoming ASCO meeting)
• 2-year and 3-year survival data for an expanded Phase 1b dose-ranging study of Nivolumab (as a monotherapy) for patients with advanced melanoma (will be presented at the upcoming ASCO meeting)
• Phase 2 and Phase 1b study of Nivolumab as a monotherapy and in combination with Yervoy (Ipilimumab) for patients with RCC (will be presented at the upcoming ASCO meeting).
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