Guidance

Project Orbis

Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.

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.

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. 

Authorisations will be applicable in Great Britain only as oncology medicinal products fall within the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland. 

You can find out more on  the EMA website

The FDA  coordinates the selection of products that will be included. Initial enquiries that 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 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. MHRA  will arrange a meeting with you to discuss eligibility. 

Types of submissions

There are three different types of submission depending on the timelines between the FDA and MHRA.

Type A

Applications should be submitted concurrently or near-concurrently (within 30 days) to FDA and 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 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 MHRA but there is no concurrent review or action with FDA.

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 submission2
Submission overlaps with FDA Expected Expected Permitted2
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 Possible1 No1 No1

1 Regulatory action in other jurisdictions is unlikely to occur immediately after FDA action and will follow respective health authority timelines.

2Dependent on Project Orbis Partner (POP) guidelines. Contact specific POP(s) regarding optimal timing for submission of Type C dossier.

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 MHRA.  

MHRA participation is contingent on agreement with the UK affiliate.

Fees

You will need to pay the relevant national authorisation fee for any applications made to Project Orbis.

Find out more about our fees

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.

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.

Overview of Orbis Project approvals

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.

Find out more

If you would like any more information or have any questions you can email Orbis-MHRA@mhra.gov.uk.

Published 10 December 2020
Last updated 12 January 2024 + show all updates
  1. 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.

  2. Updated to include Opdualag to ORBIS list

  3. Jemperli has been added to the Overview of Orbis Project approvals.

  4. Tabrecta is a new Project Orbis approval

  5. Information on IMFINZI

  6. Added NUBEQA to Orbis Project approvals list

  7. Added OPDIVO - Variation to add a new therapeutic indication

  8. REZUROCK added to 'approvals' list.

  9. Welireg & Kimmtrak added to Project Orbis Approvals table.

  10. Jakavi and EXKIVITY added to Project Approval list.

  11. Added Project Orbis section

  12. First published.