Project Orbis
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
1.Overview
The programme provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies.
Project Orbis is coordinated by the US Food and Drug Administration (FDA). Alongside MHRA, it involves the regulatory authorities of:
- Australia (Therapeutic Goods Administration (TGA))
- Canada (Health Canada)
- Singapore (Health Sciences Authority (HSA))
- Switzerland (Swissmedic)
- Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))
- Israel (Ministry of Health)
Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision.
2. Products eligible for Project Orbis
Applications submitted to the MHRA within a Project Orbis procedure must be new marketing authorisation applications (MAAs) or new indication applications (variations) for oncology products.
When the Windsor Framework comes into force from 1 January 2025[1] authorisations granted through this programme will be applicable UK-wide. Until that date authorisations are limited to Great Britain only because medicinal products containing new active substances for the treatment of cancer fall within the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland.
You can find out more from our UK-wide licensing guidance.
The FDA coordinates the selection of products that will be included. Initial enquiries that the MHRA receive will be referred to the FDA. Submissions do not require an Innovation Passport designation for inclusion in the Project Orbis programme, though applicants can also apply for the Innovation Passport within the Innovative Licensing and Access Pathway (ILAP) if they wish to.
You can find out more in our guidance about ILAP.
Submissions will need to meet the FDA’s clinical criteria for priority review.
If you want the MHRA to submit a product or new indication for the Project Orbis programme, email Orbis-MHRA@mhra.gov.uk with a summary of the product explaining how you meet the eligibility criteria. The MHRA will arrange a meeting with you to discuss eligibility.
3. Types of submissions
There are three different types of submission depending on the timelines between the FDA and the MHRA.
Type A
Applications should be submitted concurrently or near-concurrently (within 30 days) to the FDA and the MHRA. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action with the FDA.
Type B
Applications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of the FDA action are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review with FDA but no concurrent action.
Type C
If the FDA has already taken regulatory action, a Type C Orbis (Written Report Only Orbis) will allows the FDA to share their completed review documents with the MHRA but there is no concurrent review or action with the FDA.
Table 1: Project Orbis Types
| Orbis Type | Type A | Type B | Type C |
|---|---|---|---|
| Submission Timeline | Application submission to POPs ≤ 1 month of FDA submission | Application submission to POPs > 1 month of FDA submission | Any time after FDA submission[2] |
| Submission overlaps with FDA | Expected | Expected | Permitted[2] |
| Sharing of FDA reviews | Yes | Yes | Yes |
| Multi-country review meetings (POP TCONs) | Yes | Yes | No |
| POP Attendance at FDA review meetings | Yes | Yes | Unlikely |
| Concurrent review with FDA | Expected | Possible | Unlikely |
| Near concurrent action with FDA | Possible[3] | No[3] | No[3] |
[2] Dependent on Project Orbis Partner (POP) guidelines. Contact specific POP(s) regarding optimal timing for submission of Type C dossier.
[3] Regulatory action in other jurisdictions is unlikely to occur immediately after FDA action and will follow respective health authority timelines.
4. Inclusion of the MHRA in a Project Orbis Procedure
Once a product or new indication has been identified for inclusion in Project Orbis, FDA will contact the MHRA to request their interest in involvement. If the request is provisionally accepted by the MHRA, the parent US Company will be advised and should provide details of the local UK affiliate to the MHRA.
MHRA participation is contingent on agreement with the UK affiliate.
5. Fees
You will need to pay the relevant national authorisation fee for any applications made to Project Orbis.
Find out more about our fees.
6. Assessment process and expert advice
The multidisciplinary assessment teams will carry out the assessment of the application.
The assessment process will include consultation with the MHRA Expert Advisory Groups and the Commission on Human Medicines, as required.
7. Publication
The granting of a Great Britain marketing authorisation or new indication through Project Orbis will lead to publication of a Great Britain Public Assessment Report.
8. Overview of Orbis Project approvals
Table 2
| Product | Type of Project | New Indication | Grant Date |
|---|---|---|---|
| Tagrisso | Variation to add a new therapeutic indication | Tagrisso as a monotherapy is indicated for the adjuvant treatment after complete tumour resection in adult patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations | 06/05/2021 |
| Trovdelvy | Initial licence application | TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease (see section 5.1). | 08/09/2021 |
| Lorviqua | Variation to add a new therapeutic indication | Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. | 23/09/2021 |
| Lumykras | Initial licence application | LUMYKRAS is indicated as monotherapy for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy. | 08/09/2021 |
| RYBREVANT | Initial licence application | RYBREVANT as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. | 15/11/2021 |
| TEPMETKO | Initial licence application | TEPMETKO is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. | 24/09/2021 |
| Tecentriq | Variation to add a new therapeutic indication | Tecentriq as monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC-staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy. | 27/01/2022 |
| Jakavi | Variation to add a new therapeutic indication | Graft versus host disease (GvHD) - Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids. Jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft versus host disease who have inadequate response to corticosteroids. (see Section 5.1) | 23/03/2022 |
| EXKIVITY | Initial licence application | EXKIVITY as monotherapy is indicated for the treatment of adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior platinum-based chemotherapy | 17/03/2022 |
| Welireg | Initial licence application | Welireg is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable. | 31/05/2022 |
| Kimmtrak | Initial licence application | KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. | 07/06/2022 |
| REZUROCK | Initial licence application | Rezurock is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) who have received at least two prior lines of systemic therapy. | 07/07/2022 |
| OPDIVO | Variation to add a new therapeutic indication | Neoadjuvant treatment of NSCLC OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer in adults | 16/08/2022 |
| NUBEQA | Variation to add a new therapeutic indication | metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel (see section 5.1) | 22/11/2022 |
| IMFINZI | Variation to add a new therapeutic indication | IMFINZI in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC). | 25/01/2023 |
| Tabrecta | Initial licence application | Tabrecta, as monotherapy, is indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. | 27/03/2023 |
| Jemperli | Variation to add a new therapeutic indication | JEMPERLI is indicated in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability high (MSI H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. | 02/10/2023 |
| Opdualag | Initial licence application | Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. | 27/12/2023 |
Further details on the approval can be found on the Public Assessment Report.
The page will be updated on each Orbis project approval.
9. Further information
For more information or any questions please email Orbis-MHRA@mhra.gov.uk.
[1] Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14
Updates to this page
Last updated 18 October 2024 + show all updates
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• Added section numbers and overview section • Updated section 2 for clarity and to add details of changes with respect to the Windsor Framework
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Truqab has been added to the Overview of Orbis Project approvals
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The MHRA has recently updated its guidance in relation to Project Orbis and ILAP. There is no longer a requirement to obtain an Innovation Passport as part of the Project Orbis programme.
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Updated to include Opdualag to ORBIS list
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Jemperli has been added to the Overview of Orbis Project approvals.
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Tabrecta is a new Project Orbis approval
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Information on IMFINZI
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Added NUBEQA to Orbis Project approvals list
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Added OPDIVO - Variation to add a new therapeutic indication
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REZUROCK added to 'approvals' list.
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Welireg & Kimmtrak added to Project Orbis Approvals table.
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Jakavi and EXKIVITY added to Project Approval list.
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Added Project Orbis section
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First published.