NEW YORK – Strata Oncology said this week that Gilead Sciences will provide Trodelvy (sacituzumab govitecan) for the ongoing Strata PATH basket trial of multiple FDA-approved cancer therapies in biomarker-guided patient populations. The trial will enroll about 700 patients with advanced cancer or early-stage cancer with evidence of micrometastases after initial therapy.
Orphagen Pharmaceuticals this week was granted rare pediatric disease designation by the US Food and Drug Administration for its SF-1 antagonist, OR-449, as a treatment for pediatric adrenocortical carcinoma. The company is developing OR-449 for both pediatric and adult adrenal gland cancers, along with other tumors that express high levels of SF-1. Orphagen CEO Scott Thacher said in a statement that the firm plans to file an investigational new drug application for OR-449 later this year to study the drug in adrenal gland cancers.
Hutchmed said this week that the China National Healthcare Security Administration has included Orpathys (savolitinib) on its National Reimbursement Drug List, effective March 1, 2023, as treatment for locally advanced or metastatic non-small cell lung cancer patients whose tumors harbor MET exon 14-skipping alterations and have progressed following chemotherapy. Hutchmed and AstraZeneca jointly develop Orpathys, though Hutchmed is responsible for commercializing the agent in China.
MD Anderson Cancer Center this week announced licensing agreements with BostonGene and Tempus for its EGFR mutation classification system in non-small cell lung cancer. The system is designed to classify EGFR mutations into subgroups based on their structural changes and how sensitive they are to EGFR inhibitors, which MD Anderson researchers believe to be more effective as predictive biomarkers than exon-based groupings. Under the licensing agreements, BostonGene and Tempus will both include the EGFR subgroup classification in their clinical reports for NSCLC patients.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.