Entrectinib (RXDX-101), an investigational anticancer agent being developed by Ignyta, is a game-changer for NTRK/ROS1/ALK fusion-positive solid tumors.
The San Diego, California-based biotechnology company is attracting attention for its orally available central nervous system (CNS) active tyrosine kinase inhibitor, entrectinib, which is in a strong position to progress to market, according to researchers at GlobalData, a leading data and analytics company.
The drug has already been granted an FDA breakthrough therapy designation in May 2017 and an FDA orphan drug designation in July 2017.
On October 17, the EMA awarded entrectinib a Priority Medicines (PRIME) designation, following the company’s release of its updated clinical trial results for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
?The PRIME designation allows Ignyta to have enhanced support from the regulatory body, including optimizing the development pathway and engaging in early discussions with both the EMA and health technology assessment bodies in Europe.
This initiative will place the multi-targeted kinase inhibitor on a faster path to approval and ease subsequent access barriers,? noted Ashwin Oberoi, Healthcare Analyst at GlobalData.
The ongoing, global, multicenter, open-label, Phase II STARTRK-2 trial is evaluating entrectinib in a basket trial design, in which patients with a variety of tumor types are eligible for the therapy.
As part of this basket trial design, entrectinib is currently being analyzed in NSCLC, salivary gland cancer, pancreatic cancer, metastatic colorectal cancer (mCRC), neuroblastoma, and papillary thyroid cancer.
“The multi-kinase inhibitor entrectinib has proven to have a drastic effect in the NTRK, ROS1, and ALK fusion-positive solid tumor patient cohorts. With Ignyta?s positive Phase II data in an NSCLC population, enhanced regulatory body support from both the EMA and FDA, and significant capital raised, the company should be in a robust position to drive its prized asset through to the finish line,” Oberi continued:
?However, Ignyta?s upcoming planned Phase III trial and data readouts will be critical for determining entrectinib?s future in the precision medicine space for patients with advanced and metastatic solid tumors,? he concluded.
Last Editorial Review: November 17, 2017
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