Study Overview: Bristol-Myers Squibb is conducting a Phase 3 trial titled Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or ...

ROS1 rearranged or ROS1-positive non-small cell lung cancer is a subtype of lung cancer that is — makes up about 1 to 2% of non-small cell lung cancer. And it's a … really interesting subtype, because ...

Additionally, among patients who had been pretreated with 1 prior ROS1 TKI and no prior chemotherapy (n = 56), the ORR was 38% (95% CI, 25-52) and the mDOR was 14.8 months.

Although ROS1 mutations are quite rare in patients with non-small cell lung cancer (NSCLC), testing for the mutation in all who have the disease is important, as it can play a vital role in ...

Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment ...

A Validation Study for the Use of ROS1 Immunohistochemical Staining in Screening for ROS1 Translocations in Lung Cancer. Journal of Thoracic Oncology, 2016; DOI: 10.1016/j.jtho.2016.03.019 ...

FDA approval of IBTROZI (taletrectinib) transformed Nuvation Bio into a commercial-stage company, driving $4.8 million in GAAP revenue, well above GAAP revenue estimates. Earnings per share (GAAP) was ...

FDA written guidance confirms that data from completed and ongoing studies are sufficient for NDA submission in ROS1 fusion-positive non-small cell lung cancer (NSCLC) ROS1 program has achieved ...

The efficacy of ceritinib in this population of previously treated, crizotinib-naïve patients with ROS1-positive NSCLC is impressive and rivals that seen with crizotinib in PROFILE 1001. Of note, ...