Project Orbis lets FDA and eight partner regulators review cancer drug applications at the same time. Here is how it works, who joins, and how sponsors use it.
Last updated: November 14, 2026
Quick answer: Project Orbis is a program run by the FDA’s Oncology Center of Excellence since May 2019 that lets FDA and partner regulators in Australia, Brazil, Canada, Israel, Japan, Singapore, Switzerland and the UK review the same oncology application concurrently. Each agency still makes its own decision.
Scope: what Project Orbis is, who participates, how a sponsor gets in, how it connects to RTOR and the Assessment Aid, and a planning framework for regulatory teams. Program facts come from FDA’s Project Orbis pages, content current as of October 29, 2026.
What is Project Orbis?
Project Orbis is FDA’s framework for concurrent submission and review of oncology products with international partners. The FDA Oncology Center of Excellence (OCE) started it in May 2019. The goal is earlier patient access in countries where cancer drug submissions often lag the US, whether or not the product is already FDA approved.
The program does not create a shared approval. FDA’s FAQ is direct about this: each agency conducts its own review and keeps independence over its final regulatory decision, labeling negotiations and timelines. What Orbis shares is the work in the middle: review timing, information requests and regular calls between agencies.
FDA says the first collaborative review involved Australia’s Therapeutic Goods Administration and Health Canada, for an endometrial carcinoma product. Since then the program has become routine for major oncology applications. The latest example is the November 13, 2026 approval of durvalumab (Imfinzi) with enfortumab vedotin (Padcev) in bladder cancer, reviewed with six Orbis partners.
Which countries are in Project Orbis?
FDA lists eight partner regulators alongside itself. The European Medicines Agency is not a partner, which is the single most important planning fact for global sponsors.
| Country | Regulator |
|---|---|
| Australia | Therapeutic Goods Administration (TGA) |
| Brazil | National Health Surveillance Agency (ANVISA) |
| Canada | Health Canada |
| Israel | Ministry of Health, Pharmaceutical Administration |
| Japan | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Singapore | Health Sciences Authority (HSA) |
| Switzerland | Swissmedic |
| United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) |
FDA’s FAQ says it is currently unable to increase the number of participating countries. Sponsors should not plan around new partners joining soon.
Which applications are eligible?
Oncology NDAs, BLAs and supplemental applications are eligible, and FDA’s criteria include but are not limited to high impact and clinically significant applications. The program sits inside OCE, so other therapeutic areas are outside its scope.
Either side can start the conversation. Sponsors can request Orbis when international collaboration could get cancer patients earlier access, and FDA review teams can also recommend an application to a sponsor. FDA’s pages do not tie eligibility to priority review, though the three recent Orbis approvals in the table below were all priority reviews.
| Recent approval (FDA notice) | Date | Orbis partners named |
|---|---|---|
| Imfinzi + Padcev, cisplatin ineligible MIBC (VOLGA) | Nov 13, 2026 | TGA, ANVISA, Health Canada, Israel MoH, HSA, MHRA |
| Keytruda + Padcev, all cystectomy candidates (KEYNOTE-B15/EV-304) | Jul 10, 2026 | TGA, Health Canada, Swissmedic, MHRA, Israel MoH |
| Keytruda + Padcev, cisplatin ineligible MIBC (KEYNOTE-905/EV-303) | Nov 21, 2025 | TGA, Health Canada, Swissmedic, MHRA |
The table shows that partner lists vary by application. A sponsor chooses where to file, and partners choose whether to collaborate on each submission.
How does a sponsor request Project Orbis?
The sponsor asks the relevant Office of Oncologic Diseases review division whether the submission suits Orbis, then submits a Project Orbis Request for Participation and Global Submission Plan. From there FDA runs the coordination.
The steps, per FDA’s FAQ:
- The sponsor or the FDA review team nominates the application.
- FDA notifies the OCE global team, which asks partners whether they want to collaborate.
- FDA tells the sponsor which partners are in.
- The sponsor sends a Sponsor Authorization Letter (SAL) for those countries, which lets the agencies share information. A new SAL is needed for each supplement.
- Partners hold scheduled calls. Information requests are shared among partners before going to the sponsor, and the sponsor sends responses to every agency that received the application.
FDA encourages submission to all interested partners, but the final decision on where to file stays with the sponsor.
Does Project Orbis change FDA review timelines?
No. FDA follows its normal review timelines and processes, and it can approve even while partners are still working through their own questions. Participation also does not change Real Time Oncology Review timelines.
The time benefit lands outside the US. Partners see the application on roughly the same clock as FDA instead of after it. FDA’s pages do not publish program wide time savings, and we did not find an FDA figure for that. A 2024 Lancet Oncology analysis by Zosso-Pavic and colleagues studied Swiss participation from 2020 to 2022 and is listed on FDA’s page; we could not retrieve its figures, so we do not cite them.
One wrinkle for public tracking: FDA says listings for Type C Orbis approvals may be delayed beyond the FDA approval date while global submission plans and authorization letters are finalized. FDA maintains an Orbis approvals database updated quarterly; the latest version listed is dated April 22, 2026.
How do RTOR and the Assessment Aid fit with Orbis?
They are separate OCE tools that often run together on the same application. Real Time Oncology Review lets sponsors send topline efficacy and safety results before the full application. The Assessment Aid is a voluntary, structured summary that the sponsor drafts and FDA completes. Orbis adds the international layer on top.
| Program | What it does | Who it helps | Key rules (FDA pages) |
|---|---|---|---|
| Project Orbis | Concurrent review with partner regulators | Patients and sponsors outside the US | Oncology NDAs, BLAs, supplements; independent decisions; SAL required |
| Real Time Oncology Review (RTOR) | Early submission of topline data before the complete application | FDA review efficiency | Division decides in about 20 business days; about 22 weeks from topline to complete submission as a general guideline; up to three presubmissions; final guidance November 2023 |
| Assessment Aid | Structured review document with data, applicant position and FDA assessment | FDA reviewers, sponsors | Voluntary; 100 page limit for NMEs, 75 for supplements; Microsoft Word; no impact on timelines if not used |
The VOLGA approval used Orbis and the Assessment Aid together. FDA’s RTOR page says PDUFA timelines are not affected by RTOR, and RTOR applies to CDER drug applications, not CDRH devices.
What Project Orbis does not do
Orbis does not harmonize labels, set prices or allow importation. FDA’s FAQ answers the pricing and importation question with a single word: no. Each agency negotiates its own label, which means the final indication wording can differ country to country even after a joint review.
It is also not a mutual recognition agreement. An FDA approval does not bind the TGA, Health Canada or any other partner, and a partner can ask for more data, approve later or decline.
How should regulatory teams plan for Project Orbis? (our framework)
This is our planning checklist for oncology regulatory and market access teams. It is not FDA guidance.
- Raise Orbis at the pre NDA or pre BLA meeting. Ask the review division about suitability early, alongside RTOR and Assessment Aid plans.
- Build the global submission plan in parallel with the US dossier. Partner filings need local requirements, translations and agents ready on the US timeline.
- Decide which partners to file with based on launch priorities, not by default; the sponsor makes the final call.
- Prepare Sponsor Authorization Letters for each country, and remember a new SAL is needed for each supplement.
- Set up one response process for shared information requests so every agency gets the same answer at the same time.
- Plan the EU separately. The EMA is not an Orbis partner, so EU timing runs on its own track.
- Align market access early. Faster regulatory approval in Australia, Canada or the UK does not speed reimbursement; health technology assessment still runs on its own clock.
- Track public listings. Orbis approvals may appear in FDA’s database later than the US approval, especially for Type C reviews.
What to watch next
- Partner decisions on the VOLGA application from the six agencies named by FDA.
- The next quarterly update to FDA’s Orbis approvals database.
- Whether FDA reopens the partner list, which its FAQ currently rules out.
- How FDA staffing and review changes in 2026 affect OCE’s international programs.
- PDUFA VIII negotiations and any commitments touching global collaboration.
FAQ
What is Project Orbis in simple terms?
It is an FDA program that lets the FDA and partner regulators in eight countries review the same cancer drug application at roughly the same time, so patients outside the US can get access sooner.
When did Project Orbis start?
The FDA Oncology Center of Excellence launched Project Orbis in May 2019.
Which countries participate in Project Orbis?
Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Israel (Ministry of Health), Japan (PMDA), Singapore (HSA), Switzerland (Swissmedic) and the UK (MHRA), plus the FDA.
Is the European Medicines Agency part of Project Orbis?
No. The EMA is not on FDA’s list of Project Orbis partners, so EU reviews run separately.
Do Project Orbis partners have to follow FDA’s decision?
No. Each agency conducts its own review and keeps independence over its decision, labeling and timeline.
What drugs qualify for Project Orbis?
Oncology NDAs, BLAs and supplemental applications, with criteria that include high impact and clinically significant applications. Non oncology drugs are outside the program.
How does a company apply for Project Orbis?
The company asks its Office of Oncologic Diseases review division about suitability, then submits a Project Orbis Request for Participation and Global Submission Plan.
What is a Sponsor Authorization Letter?
It is the letter a sponsor sends so FDA and the chosen partner agencies can share information about its application. A new one is required for each supplement.
Does Project Orbis make FDA approval faster?
No. FDA follows its normal timelines. The speed benefit is for partner countries, which review alongside FDA instead of later.
Does Project Orbis affect drug prices?
No. FDA states that Project Orbis has nothing to do with drug pricing or drug importation.
What is the difference between Project Orbis and RTOR?
RTOR lets a sponsor send topline data to FDA before the full application, improving FDA’s own review. Orbis coordinates review with other countries. One application can use both.
What is the FDA Assessment Aid?
A voluntary structured document for oncology applications, with sections for the data, the applicant’s position and FDA’s assessment, limited to 100 pages for new molecular entities and 75 for supplements.
Sources
- FDA Oncology Center of Excellence, Project Orbis page, content current as of October 29, 2026 (primary).
- FDA, Project Orbis Frequently Asked Questions, content current as of October 29, 2026 (primary).
- FDA, Real Time Oncology Review page, content current as of November 18, 2024 (primary).
- FDA, Assessment Aid page, content current as of November 18, 2024 (primary).
- FDA approval notices: durvalumab with enfortumab vedotin-ejfv (Nov 13, 2026); pembrolizumab with enfortumab vedotin-ejfv (Nov 21, 2025 and Jul 10, 2026) (primary).
- Zosso-Pavic M, et al., The Lancet Oncology, 2024, on Swiss Project Orbis participation (listed on FDA’s page; figures not retrieved, not cited).
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