The US Food and Drug Administration last month granted accelerated approval to a new cancer drug for adult and pediatric patients with solid tumors that have a specific genetic mutation detectable through Oncomine Comprehensive, an advanced Next Generation Sequencing (NGS) test co-developed by EIPM and the Weill Cornell Medicine Pathology department.
According to the FDA, the powerful new cancer drug larotrectinib is effective for patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
“The Oncomine Comprehensive test is a targeted NGS panel that can rapidly identify clinically significant somatic mutations including single nucleotide variants (SNVs), insertions and deletions (Indels), gene fusions and copy number alterations from DNA and RNA of 143 cancer-related genes in solid tumors,” said Jeffrey Catalano, Operations Manager in the WCM Clinical Genomics Laboratory. “It is reliable for detecting the full range of NTRK fusions, and can help determine if this new cancer drug is indicated for specific patients.”
NTRK gene fusions are oncogenic drivers of adult and pediatric tumor types, and treatment of patients with these NTRK fusion-positive cancers with drugs like larotrectinib is associated with high response rates.
“We thank the FDA for their action in granting accelerated approval of larotrectinib, which will greatly benefit a subset of adult and pediatric cancer patients who have diminished options in fighting their disease, and we urge New York-area oncologists to contact Weill Cornell Medicine to schedule an Oncomine Comprehensive test today for their patients,” said Olivier Elemento, Ph.D., Director of the Englander Institute for Precision Medicine at WCM.