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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聽MHRA, it involves the regulatory authorities of:

• Australia (Therapeutic Goods Administration (TGA))
• Canada (Health Canada)
• Singapore (Health Sciences Authority (HSA))
• Switzerland (Swissmedic)
• Brazil (Ag锚ncia Nacional de Vigil芒ncia Sanit谩ria (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鈥疢HRA聽within a Project Orbis procedure must be new marketing authorisation applications (MAAs) or new indication applications (variations) for oncology products.听

When the Windsor Framework came into force 1 January 2025, authorisations granted through this programme were applicable UK-wide.听Before that date authorisations were 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.听

You can find out more from our UK-wide licensing guidance.

The鈥疐DA鈥痗oordinates the selection of products that will be included. Initial enquiries that鈥� the MHRA鈥痳eceive will be referred to the鈥疐DA. 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.听聽

You can find out more in our鈥���guidance about鈥疘LAP.听

Submissions will need to meet the鈥疐DA鈥檚 clinical criteria for priority review.听

If you want the聽MHRA聽to submit a product or new indication for the Project Orbis programme, email聽[email protected]聽聽with a summary of the product explaining how you meet the eligibility criteria.听The MHRA will arrange a meeting with you to discuss eligibility.听

3. 聽Types of submissions

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

Type A

Applications should be submitted concurrently or near-concurrently (within 30 days) to the聽FDA聽and the聽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聽the FDA.

Type B

Applications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of the聽FDA聽action are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review with聽FDA聽but no concurrent action.

Type C

If the聽FDA聽has already taken regulatory action, a Type C Orbis (Written Report Only Orbis) will allows the聽FDA聽to share their completed review documents with the MHRA but there is no concurrent review or action with the聽FDA.

Table 1: Project Orbis Types

Orbis Type	Type A	Type B	Type C
Submission Timeline	Application submission to POPs 鈮� 1 month of聽FDA聽submission	Application submission to POPs > 1 month of聽FDA聽submission	Any time after聽FDA submission[2]
Submission overlaps with聽FDA	Expected	Expected	Permitted[2]
Sharing of聽FDA聽reviews	Yes	Yes	Yes
Multi-country review meetings (POP TCONs)	Yes	Yes	No
POP Attendance at聽FDA聽review meetings	Yes	Yes	Unlikely
Concurrent review with聽FDA	Expected	Possible	Unlikely
Near concurrent action with聽FDA	Possible[3]	No[3]	No[3]

[2]聽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聽FDA聽action and will follow respective health authority timelines.

4. 聽Inclusion of the聽MHRA聽in a Project Orbis Procedure

Once a product or new indication has been identified for inclusion in Project Orbis,鈥疐DA鈥痺ill contact the鈥疢HRA聽to request their interest in involvement. If the request is provisionally accepted by the鈥疢HRA, the parent US Company will be advised and should provide details of the local UK affiliate to the鈥疢HRA.鈥���

MHRA鈥痯articipation is contingent on agreement with the UK affiliate.

5. 聽Fees

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

Find out more about聽our fees.

6. 聽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聽MHRA聽Expert Advisory Groups and the Commission on Human Medicines, as required.

7. 聽Publication

The granting of a UK marketing authorisation or new indication through Project Orbis will lead to publication of a UK Public Assessment Report.

8. 聽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	6 May 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).	8 September 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 September 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 September 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 November 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 September 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 鈮� 50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy.	27 January 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 March 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 March 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 May 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 June 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 July 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 鈮� 4 cm or node positive) non-small cell lung cancer in adults	16 August 2022
NUBEQA	Variation to add a new therapeutic indication	metastatic hormone鈥憇ensitive prostate cancer (mHSPC) in combination with docetaxel (see section聽5.1)	22 November 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 January 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 March 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 October 2023
Opdualag	Initial licence application	Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12聽years of age and older.	27 December 2023
Truqap	Initial licence application	Truqap is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)聽positive, human epidermal growth factor receptor聽2 (HER2)聽negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen (see section 5.1).	17 July 2024

Further details on the approval can be found on the聽.

The page will be updated on each Orbis project approval.

9. Further information

For more information or any questions please email聽[email protected].