...China has approved the New Drug Application (NDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), based on results from the TRIDENT-1 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023.

Turning Point Therapeutics...announced the U.S. Food and Drug Administration (FDA) granted an eighth regulatory designation, and third Breakthrough Therapy designation, to lead drug candidate repotrectinib....Breakthrough Therapy designation (BTD) was granted for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688)...today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic non-small-cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI). The breakthrough therapy designation for repotrectinib was supported by the initial data from both global and Chinese TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.

Turning Point Therapeutics...today announced the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib....The Fast-Track designation was granted for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with one prior ROS1 tyrosine kinase inhibitor (TKI) and who have not received prior platinum-based chemotherapy.

Turning Point Therapeutics...today announced its lead drug candidate, repotrectinib, has been granted breakthrough therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI-naïve).

Pts with ROS1+ NSCLC were assigned to 4 cohorts by treatment history: TKI-naïve, 1 TKI and no chemo, 1 TKI and 1 platinum-based chemo, and 2 TKIs and no chemo. Repotrectinib RP2D was 160 mg once daily for 14 days, then 160 mg twice daily....With a minimum follow-up of 14 mo in TRIDENT-1, repotrectinib continued to demonstrate durable efficacy in pts with ROS1+ NSCLC, including intracranial activity, in both TKI-naïve and 1 prior TKI and no chemo cohorts.

Zai Lab Limited...announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC)....Zai Lab and Turning Point Therapeutics...are studying repotrectinib in TRIDENT-1, a registrational Phase 1/2 study in adults, and CARE, a Phase 1/2 study in pediatric patients.

Patients with ROS1+ NSCLC were assigned to 1 of 4 expansion cohorts….In TKI-naïve patients, cORR (95% CI) was 79% (68, 88); 12-month DOR (95% CI) was 86% (76, 96); 12-month PFS (95% CI) was 80% (70, 90). Additional efficacy data, including outcomes in TKI-pretreated cohorts and cORR by age, are shown in the Table. In TKI-pretreated patients with ROS1 G2032R NSCLC (n = 17), cORR was 59% (6-month DOR [95% CI]: 70% [42, 98])....In both TKI-naïve and TKI-pretreated patients with ROS1+ advanced NSCLC, repotrectinib achieves durable activity, including intracranial responses, and responses in those with ROS1 G2032R.

Zai Lab Limited...announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.

….Phase 2 TRIDENT-1 study as they reaffirm our belief that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1- or NTRK-driven tumors, including patients who are TKI-naïve and TKI-pretreated...In the ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC) population (EXP-1: n=7)...Six patients achieved a confirmed response for an Objective Response Rate (ORR) of 86 percent.