Atossa Therapeutics, a clinical-stage biopharmaceutical company, has completed a Type C meeting with the FDA to discuss advancing (Z)-Endoxifen in breast cancer treatment and prevention.
The meeting focused on potential expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settings.
Atossa is pursuing a faster and more focused development strategy across multiple breast cancer indications.
FDA Meeting Outcome
Feedback from the FDA clarified potential routes for accelerated clinical development and regulatory review for (Z)-Endoxifen.
Clinical Program Advancements
Atossa is progressing with dose-ranging studies for metastatic breast cancer, enrollment in the Phase 2 EVANGELINE trial for Neoadjuvant ER+/HER2- breast cancer, and developing strategies for breast cancer risk-reduction.
Proprietary Formulation of (Z)-Endoxifen
Atossa is developing an enteric oral formulation of (Z)-Endoxifen to enhance bioavailability and therapeutic integrity.
- The FDA meeting marks a significant milestone in Atossa's program development, potentially shortening the regulatory timeline.
- Atossa's clinical studies have demonstrated the safety and efficacy of (Z)-Endoxifen, supporting its advancement across various clinical settings.
Atossa's focused approach and innovative strategies highlight its commitment to transforming breast cancer treatment and prevention.