Bayer's Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors
Shots:
- The US FDA has granted full approval to Vitrakvi for adults & pediatrics with NTRK fusion-positive metastatic or inoperable solid tumors, who had disease progression on prior therapy or lacked alternative therapy options
- Approval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were ORR & DoR per RECIST v1.1; safety was assessed in 444 pts across studies
- Pooled efficacy showed mDoR of 43.3mos. & ORR of 60%, incl. 24% CR rate & 36% PR rate, with pCR observed in 5% pts, defined as no viable tumor cells & negative margins post-surgery with no other disease sites
Ref: Businesswire | Image: Bayer
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