Project Orbis

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))

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 coordinate the selection of products that will be included. Initial enquires that MHRA receive will be referred to the FDA.

Submissions will only be forwarded to the FDA if they meet the qualifying criteria for the Innovation Passport within the Innovative Licensing and Access Pathway (ILAP).

MHRA, NICE and the Scottish Medicines Consortium (SMC) will collaborate within ILAP and a positive Innovation Passport designation is a requirement for inclusion in the Project Orbis programme.

You can find out more in our guidance about ILAP

Submissions will also need to meet the FDA’s clinical criteria for priority review.

If you want MHRA to propose 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.

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 and inclusion of the product or new indication in ILAP.

If the product or new indication is not already accepted for ILAP, the MHRA will arrange an Innovation Passport meeting as soon as possible after the request for inclusion in Project Orbis to confirm eligibility based on a review of the top-level clinical data. The meeting will also address practical arrangements for the submission, including the requirements for:

• orphan products
• paediatric investigation plans (PIPs)
• pharmacovigilance including risk management plans (RMPs).

Requests for meetings should be emailed to Orbis-MHRA@mhra.gov.uk. MHRA will then arrange a mutually acceptable date for the meeting.

For products and new indications already accepted in ILAP, a meeting will be arranged to discuss practical arrangements for submission.

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	06/05/21
Trovdelvy	Initial licence application	TTRODELVYTRODELVY 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).	09/09/2108/09/21
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.	23/09/21
LumakrasLumykras	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.	08/09/21
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.	15/11/21
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.	24/09/21
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.	27/01/22
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

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.