Shots:

• The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for NTRK fusion-positive advanced or recurrent solid tumors
• The P-III NAVIGATE trial showed ORR (65.2%)- CR (16.9%)- and P-I/II SCOUT trial showed ORR (88.9%)- CR (22.2%). In general- the studies demonstrated high response rates- durable responses- and a favorable safety profile in adults and children with TRK fusion cancer
• The approval follows the approval of the expanded use of FoundationOne CDx in Japan for use as a CDx to identify patients with TRK fusion cancer who are expected to benefit from treatment with Vitrakvi

 ­ Ref: Bayer | Image: Industry Week