Starpharma (ASX: SPL, US OTC: SPHRY) has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its DEP® SN38 (DEP® irinotecan) program for patients with platinum-resistant ovarian cancer. The meeting with the FDA aimed to confirm regulatory approval pathways and seek guidance on the design of a Phase 2/3 clinical program for registration of DEP® SN38 in the US.
FDA Feedback Highlights
The FDA agreed to consider DEP® SN38 for Fast Track designation, recognizing platinum-resistant ovarian cancer as a serious condition with significant unmet medical need. The agency also confirmed that a 505(b)(2) regulatory approval pathway is appropriate, as DEP® SN38 delivers the active moiety of the FDA-approved drug, irinotecan (Camptosar®). This pathway allows Starpharma to utilize existing FDA findings of safety and efficacy, potentially streamlining the approval process.
Furthermore, the FDA indicated that DEP® SN38 may qualify for accelerated approval based on an interim analysis of early surrogate endpoints from the proposed Phase 2/3 clinical trial program. The final decision will depend on the study results and overall data package. This accelerated approval could provide early access to DEP® SN38 for patients with platinum-resistant ovarian cancer.
The proposed clinical program involves comparing the safety and efficacy of DEP® SN38, alone or in combination with other anticancer agents, against single-agent chemotherapies like paclitaxel, topotecan, and pegylated liposomal doxorubicin.
Clinical Trial Design and Endpoints
During the meeting, the FDA provided valuable guidance on the study design, particularly in defining the target patient population, study endpoints, and biostatistical aspects. The agency emphasized the importance of ensuring that DEP® SN38 is applicable to a broad range of patients with platinum-resistant ovarian cancer.
Robert L. Coleman, MD FACOG FACS, a leading gynecologic oncologist, advised Starpharma on its DEP® SN38 development program and attended the FDA meeting. He commented, "Starpharma’s meeting with the FDA provided clear guidance on the most efficient path forward for the development and eventual registration of DEP® SN38 as a promising new treatment for patients with platinum-resistant ovarian cancer... the FDA demonstrated a clear, positive intention to work constructively with the company... with the goal of bringing a much-needed new therapy to patients with platinum-resistant ovarian cancer as rapidly as possible."
Company Strategy and Next Steps
Cheryl Maley, Starpharma’s Chief Executive Officer, stated, "This feedback from the US FDA marks an important milestone, supporting the IND submission, which a partner can advance through further development, registration, and commercialisation. We are encouraged by the FDA’s guidance, which validates our approach and allows us to proceed confidently with the proposed clinical pathways for DEP® SN38."
