Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

...U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity...The FDA granted the application Priority Review status...

Turning Point Therapeutics, Inc:...today announced the U.S. Food and Drug Administration (FDA) granted a seventh regulatory designation to lead drug candidate, repotrectinib....Breakthrough Therapy designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors...

Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib....The designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK tyrosine kinase inhibitors (TKIs) and have no satisfactory alternative treatments.

...Documented genetic ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required....

...Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion....

...Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary central nervous system [CNS] tumors) that harbors a ROS1 or NTRK1-3 gene fusion....

...For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented....

...Any prior lines are allowed.Cohort 3: in the EU: (1) subjects with NTRK fusions without centrally confirmed measurable disease but otherwise eligible for Cohort 2, and (2) subjects with ROS1 fusions.•Documented genetic ALK, ROS1, or NTRK1-3 alteration as identified by local testing in a CLIA laboratory in the US or equivalent. ...

...Patients with ALK, ROS1, or NTRK1/2/3 fusions are permitted to enroll in this cohort if progressed on prior targeted therapy or are...

In TRIDENT-1, with 8.7 mo minimum follow-up, repotrectinib showed robust responses and durable clinical activity in both TKI-naïve and -pretreated pts with NTRK+ solid tumors, including NSCLC.

Zai Lab Limited...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 advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with TRK tyrosine kinase inhibitors (TKIs). The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.

...enrolling pts whose cancers harbor a ROS1 or NTRK1/2/3 fusion in six phase 2 expansion cohorts (see table)....Repotrectinib was well tolerated and continues to demonstrate encouraging overall clinical activity in pts with ROS1 fusion-positive NSCLC and TRK fusion-positive solid tumors.

….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 NTRK-positive TKI-pretreated solid tumor population (EXP-6: n=6):...Three patients achieved a confirmed response for an ORR of 50 percent.

Phase I eligible pts had ALK, ROS1, or NTRK1-3 fusion-positive advanced solid tumors...Confirmed partial responses (cPR, RECISTv1.1, n = 8) were observed in TKI-naïve or TKI pre-treated ROS1+/NTRK+ pts at all dose levels....Of the 16 ALK+ pts completed 2 cycles of ropo, 4 had confirmed SD (4 cycles) as best response at data cutoff...Ropotrectinib was well-tolerated and exhibited both intra- and extra-cranial clinical activity in TKI-refractory ROS1+ and NTRK+ pts with SFM-containing tumors.