Medicines Healthcare Products Regulatory Agency
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). AlongsideMHRA, it involves the regulatory authorities of:
- Australia (Therapeutic Goods Administration (TGA))
- Canada (Health Canada)
- Singapore (Health Sciences Authority (HSA))
- Switzerland (Swissmedic)
- Brazil (Agncia Nacional de Vigilncia Sanitria (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?MHRAwithin 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?FDAs clinical criteria for priority review.
If you want theMHRAto submit a product or new indication for the Project Orbis programme, emailOrbis-MHRA@mhra.gov.ukwith 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 theFDAandthe MHRA.
Type A
Applications should be submitted concurrently or near-concurrently (within 30 days) to theFDAand theMHRA. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action withthe FDA.
Type B
Applications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of theFDAaction are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review withFDAbut no concurrent action.
Type C
If theFDAhas already taken regulatory action, a Type C Orbis (Written Report Only Orbis) will allows theFDAto share their completed review documents with the MHRA but there is no concurrent review or action with theFDA.
Table 1: Project Orbis Types
| Orbis Type | Type A | Type B | Type C |
|---|---|---|---|
| Submission Timeline | Application submission to POPs ? 1 month ofFDAsubmission | Application submission to POPs > 1 month ofFDAsubmission | Any time afterFDA submission[2] |
| Submission overlaps withFDA | Expected | Expected | Permitted[2] |
| Sharing ofFDAreviews | Yes | Yes | Yes |
| Multi-country review meetings (POP TCONs) | Yes | Yes | No |
| POP Attendance atFDAreview meetings | Yes | Yes | Unlikely |
| Concurrent review withFDA | Expected | Possible | Unlikely |
| Near concurrent action withFDA | 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 afterFDAaction and will follow respective health authority timelines.
4. Inclusion of theMHRAin a Project Orbis Procedure
Once a product or new indication has been identified for inclusion in Project Orbis,?FDA?will contact the?MHRAto 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 aboutour 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 theMHRAExpert 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
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