Skip to content

FDA Breakthrough Therapy Designation: #39 For Bristol-Myers Squibb

May 15, 2014

.

.

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 :

Num Drug Name Indication
1 3-Drug Regimen Hepatitis C
2 Daclatasvir + Asunaprevir Hepatitis C
3 Nivolumab Hodgkin Lymphoma

.

Nivolumab

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)
•   Melanoma
•   Renal Cell Carcinoma (RCC)
•   Head & Neck Cancer
•   Glioblastoma
•   Non-Hodgkin Lymphoma (NHL).

The FDA grants Fast Track designation for Nivolumab in :

•   NSCLC
•   Melanoma
•   RCC.

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).

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Glowing heart (114668824)” by 29cm from Hong Kong (Glowing heart) [CC-BY-SA-2.0] | Wikimedia Commons..

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: