信达生物（01801）公布，新一代ROS1酪氨酸激酶抑制剂（TKI）达伯乐® （己二酸他雷替尼胶囊）的第二项新药上市申请（NDA）获中国国家药品监督管理 ...

It is the only ROS1 TKI with FDA breakthrough therapy designation for locally advanced or metastatic ROS1-positive NSCLC. The FDA has granted priority review to an NDA for taletrectinib in the ...

In December 2024, Dovbleron was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC ... to see that Dovbleron ...

(NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line ... ROS1 fusion in Chinese patients with non-small cell ...

The appraisal committee has prepared final draft guidance (FDG) on crizotinib for treating ROS1-positive advanced non-small-cell lung cancer (MA review of TA529) and submitted it to NICE. The FDG has ...

DOVBLERON® was approved by China’s National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously ...

Nuvation Bio (NUVB) announced that the U.S. FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor TKI , for the treatment of ...

(NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval ... References [i] Zhang et al. Prevalence ...

In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive [i]. Furthermore, brain metastases are a common challenge, affecting up to 35% of patients newly ...