Celcuity says NCCN guidelines add newly FDA-approved REVTORPYK for advanced HR+/HER2- breast cancer
CELC•NCCN adds REVTORPYK to breast cancer guidelines
- Celcuity’s newly FDA-cleared REVTORPYK (gedatolisib) entered NCCN breast cancer treatment guidelines as a preferred second-line or later option.
- The FDA clearance was granted on July 14, 2026 for HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation.
- The decision was supported by results already generated in the Phase 3 VIKTORIA-1 trial, which showed patients stayed on disease control longer versus fulvestrant alone.
- The trial also showed more tumors shrank on REVTORPYK-based regimens than on fulvestrant alone.
- Commercial availability in the US is expected in late Q3 2026, with an expanded access program planned ahead of launch.
