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 ...

The ROS1 tyrosine kinase inhibitor (TKI) taletrectinib demonstrated high overall and intracranial responses, and a favorable safety profile with low incidence of neurologic adverse events in TKI ...

A highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI), taletrectinib was approved on June 11, 2025, based on positive outcomes in the phase 2 TRUST-II (NCT04919811) trial ...

It blocks the ROS1 proteins on the cancer cells that help the cells to grow and divide. By blocking these proteins, Ibtrozi helps shut off signals that cause abnormal cancer cell growth, which can ...

In 67 ROS1 TKI-naïve patients, the confirmed objective response rate (cORR) and disease control rate (DCR) were 92.5% and 95.5%, respectively. In 38 crizotinib-pretreated patients, the cORR and ...

Nuvalent has said it is on course to file for approval of its ROS1 inhibitor zidesamtinib as a lung cancer treatment, although rival Nuvation Bio has beaten it to market. Cambridge, Massachusetts ...

ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other ...

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 ...

In ROS1-positive NSCLC patients, the drug achieved a 79% ORR in patients who had never previously been treated with a ROS1-targeting TKI, made up of 6% complete responses and 73% partial responses ...

Nuvation Bio Inc., a clinical-stage biopharmaceutical company, focuses on developing therapeutic candidates for oncology. Its lead product candidate is taletrectinib, an ROS1 inhibitor for the ...

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 ...

Received U.S. Food and Drug Administration (FDA) approval for IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) on ...