Celcuity (CELC) FDA announcement summary

Introduction and purpose

• FDA granted full approval to REVTORPYK (gedatolisib) for HR-positive, HER2-negative, locally advanced or metastatic breast cancer without PIK3CA mutation after progression on endocrine therapy.

• REVTORPYK is the first multi-target PI3K/AKT/mTOR pathway inhibitor approved, inhibiting all class I PI3K isoforms and both mTORC1 and mTORC2 complexes.

Details of approval or decision

• Approved for use in combination with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer without PIK3CA mutation after at least one line of endocrine therapy.

• Approval based on Phase 3 VIKTORIA-1 trial showing significant reduction in risk of disease progression or death compared to fulvestrant alone.

• Recommended dosage is 180 mg IV infusion weekly on days 1, 8, and 15 of a 28-day cycle.

Impact on industry and stakeholders

• REVTORPYK targets a large, previously untapped market, with a U.S. market potential exceeding $10 billion in HR+/HER2- advanced breast cancer.

• Approval addresses a significant unmet need for improved efficacy and safety in second-line treatments for HR+/HER2- advanced breast cancer, especially for PIK3CA wild-type patients.

• Comprehensive patient support and broad payer coverage are in place to ensure rapid access and adoption.

• Market research indicates strong physician demand for new therapies in this setting due to fragmented current treatment options.

• Launch plans include robust sales force and engagement with key opinion leaders and accounts.