On December 8, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that the European Medicines Agency (EMA) has granted orphan drug designation for Ignyta’s product candidate entrectinib for the treatment of neuroblastoma (Press release, Ignyta, DEC 8, 2015, View Source [SID:1234508488]). Schedule your 30 min Free 1stOncology Demo! "We are pleased that the EMA has provided this designation for entrectinib, adding to our orphan designations in the U.S. for the treatment of neuroblastoma and the treatment of TrkA-, TrkB-, TrkC-, ROS1- or ALK-positive non-small cell lung cancer and colorectal cancer," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "Entrectinib has the potential to address unmet needs of patients with rare cancers, and we will continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of these patients."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
About Entrectinib
Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/ TrkB/TrkC), ROS1 or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against CNS metastases. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.