Project Orbis Expands: A New Era for Global Oncology Drug Approvals

Launched by the FDA’s Oncology Center of Excellence in 2019, Project Orbis is an international collaboration framework that allows for the concurrent submission and review of oncology products among participating regulatory agencies. This initiative aims to expedite patient access to promising cancer therapies by facilitating simultaneous regulatory reviews and approvals worldwide.

Since 2019, multiple life-saving therapies have received approval, with more on the horizon. This newsletter explores Project Orbis’s mission, recent developments, future opportunities, and guidance for companies seeking to participate.

🎯Key Highlights for Biopharma Stakeholders

Accelerated Global Access: By enabling parallel reviews, Project Orbis can significantly reduce the time between a product’s submission and its approval across multiple countries, ensuring patients receive timely access to new treatments.
Harmonization of Standards: The framework fosters a collaborative environment among international regulators, promoting consistency in evaluation standards and potentially harmonizing approval decisions.
Standardized Global Trials: Promote the establishment of greater uniformity in global standards of treatment, leading to the optimal design of pivotal clinical trials.

🌐Project Orbis Partners (POPs) – Active participants as of May 2025

🚀 2024–2025 Approval Highlights

Impact Metrics:

Median overall survival gain: 4.1 months (Orbis) vs 2.7 months (non-Orbis)
33% of FDA oncology approvals (2019–2023) reviewed via Project Orbis

📊 Approval Trends by Country and Indication

orbis-approval-trends-country-indication

Emerging trend: Rare and biomarker-driven indications—especially HER2+, DLL3, and NRG1 fusion cancers—are dominating Orbis approvals.

🔍Project Orbis Types Overview

🧪How to Enter Project Orbis?

Key Tip: Early engagement with the FDA can align expectations and streamline your GSP*!

⚠️ Challenges & Lessons Learned

While Orbis has transformed review timelines, it faces challenges:

Variation in partner agency timelines can still delay the harmonized launch.
Data-sharing privacy laws differ by jurisdiction.
Not all partners accept all dossier types (e.g., rolling submissions).

The FDA is addressing these with new global submission templates and a shared review portal.

🔬 Pipeline Watch: Upcoming Submissions

Project Orbis continues to serve as a pivotal platform for concurrent international review of oncology products. While the FDA does not publicly disclose all pending applications, press releases and industry announcements have identified several upcoming submissions.

BL-B01D1 (dual-targeted CAR-T for lymphoma) — Expected submission: Q3 2025
TRZ-945 (ADC for triple-negative breast cancer) — Expected submission: Q4 2025
ONC-312 (AI-designed KRAS inhibitor) — Expected submission: early 2026

Keep an eye on these assets as they move toward Orbis-accelerated global reviews.

🔮Strategic Considerations for Sponsors

Plan early: Engage with FDA and key agencies during development to align on timelines.
Keep it simple: Prepare one core dossier with flexible modules for each region.
Combine programs: Use tools like Real-Time Oncology Review (RTOR) or Assessment Aid to support faster review alongside Orbis.

Project Orbis represents a significant advancement in the global regulatory landscape for oncology products. By embracing this collaborative framework, biopharma companies can achieve more efficient and synchronized approvals, ultimately benefiting patients worldwide.

💡 How Can BLA Regulatory Help?

With deep expertise in oncology submissions and global regulatory alignment, BLA Regulatory, can guide through:

✅ Orbis eligibility assessments

✅ Harmonized Global Submission Plans (GSP)

✅ FDA and POP coordination

✅ Dossier preparation and review management

Schedule a Free Consultation

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