NEW YORK – JW Therapeutics said this week that China's National Medical Products Administration has accepted its supplemental new drug application for Carteyva (relmacabtagene autoleucel) for relapsed or refractory follicular lymphoma patients. If approved, the autologous CAR T-cell therapy could be the first cell therapy product approved in China in this setting. The treatment garnered NMPA approval for relapsed or refractory large B-cell lymphoma patients in September.
Caris Life Sciences said this week that the Tampa General Hospital Cancer Institute has joined the Caris Precision Oncology Alliance, a worldwide network of cancer centers that collaborate to advance precision oncology and biomarker-driven research. The network now comprises 59 cancer centers and academic institutions. Members have early access to Caris' database and artificial intelligence platform to establish evidence-based standards for cancer profiling and molecular testing in oncology.
AnHeart Therapeutics and Innovent Biologics this week received breakthrough therapy designation from China's National Medical Products Administration for taletrectinib as a treatment for ROS1 fusion-positive non-small cell lung cancer. The designation included both patients who have and have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI). It was based on results from the Phase II TRUST trial that showed a response rate of 90.5 percent in ROS1 TIK-naïve patients and a response rate of 43.8 percent in patients who had previously received ROS1 TKI treatment. Taletrectinib also showed activity in the study in patients with a G2032R mutation, which is associated with resistance to Pfizer's ROS1 inhibitor Xalkori (crizotinib), and in patients with brain metastases.
Mission Bio said this week that its first center of excellence, aimed at developing best practices for integrating its Tapestri platform into solid tumor research, will be located at Memorial Sloan Kettering. Jorge Reis-Filho, MSK's director of experimental pathology, will run the center. His lab plans to develop academic and industrial best practices using single-cell DNA profiling to observe tumor heterogeneity and clonal architecture in solid cancers. His team will work closely with Mission Bio's R&D team to improve nuclei extraction protocols, roll out new virtual panel content for BRCA1/2-mutant cancers and other cancer types, and enhance copy number variation analysis.
Helsinn Group and BridgeBio Pharma this week updated their license agreement for the FGFR inhibitor Truseltiq (infigratinib). Under the amended agreement, Helsinn gained an exclusive license to commercialize Truseltiq in the US and will be responsible for developing, manufacturing, and commercializing Truseltiq for oncology indications worldwide, except for mainland China, Hong Kong, and Macau. Under the previous agreement, Helsinn and BridgeBio/QED Therapeutics were codeveloping and commercializing the drug in the US. BridgeBio will retain all rights to develop, manufacture, and commercialize Truseltiq for use in skeletal dysplasia, including achondroplasia. Truseltiq was approved in the US last May for the treatment of FGFR2 fusion-positive, locally advanced or metastatic cholangiocarcinoma patients who have received prior treatment.
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.