FDA ODAC Marathon: Four Cancer Drug Applications Reviewed

Return to Normal Operations at FDA

• 💡 The Oncologic Drugs Advisory Committee (ODAC) held its first session since President Trump's inauguration, signaling a return to "business as usual" after a period of communication silence and upheaval.
• 🎯 Despite potential staffing changes, particularly among middle-level personnel at FDA Oncology, the agency demonstrated its capacity to manage a complex review process.
• 🚀 The session also featured an uncommon visit from FDA Commissioner Marty McCary and Sber Director Venet Prasad, who briefly addressed the committee.

Key ODAC Session Details

• 🗓️ The meeting was a two-day, back-to-back marathon, a rare occurrence for ODAC, which typically reviews fewer applications per session.
• 📊 A total of four drug applications were brought before the committee, a significantly higher number than usual, highlighting a backlog or increased workload.
• 💬 The discussions provided valuable insights into the logic behind drug approval and non-approval decisions, described as a "spectator sport" for clinical and scientific issues.

Four Cancer Drug Applications Reviewed

• 🔬 Genentech's glyphidab injection for diffuse B-cell lymphoma was recommended against approval due to disparate clinical trial results between Asian and non-Asian populations, raising concerns about generalizability to the US.
• ✅ Jansen Biotech's Darcellex Fax Pro for high-risk smoldering multiple myeloma received a recommendation for approval, despite questions regarding the clinical meaning of efficacy endpoints for a precursor condition and outdated diagnostic criteria.
• ⚖️ Eurogen Pharma's minim for non-muscle invasive bladder cancer resulted in a split decision, primarily because the company submitted a single-arm trial when a randomized control trial was technically feasible but halted for "business reasons."
• 🚫 Pfizer's Talzenna for metastatic castration-resistant prostate cancer was unanimously recommended against approval as it was tested in a biomarker-agnostic population without adequate powering for biomarker-negative patients.

Significance of ODAC's Role

• 🔑 The ODAC's ability to conduct such a comprehensive review underscores the critical importance of the agency's function and vision in drug regulation.
• 👏 The committee members' erudite discussions and the thorough processing of applications by FDA staff were praised, ensuring that important decisions are made with expert deliberation.