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A world where cutting-edge cancer treatments reach patients faster than ever before. That is the vision behind Project Orbis, an initiative by the US Food and Drug Administration (FDA) that brings together regulatory authorities from around the globe, including Australia, Canada, Singapore, Switzerland, Brazil, Israel, and the UK. By streamlining the submission and review process for oncology products, Project Orbis aims to accelerate access to life-saving therapies. In this article, we explore how Project Orbis operates in the UK, and its impact on cancer care.

What is Project Orbis?

Project Orbis originated from an initiative by the US Food and Drug Administration (FDA). It was created to facilitate the concurrent submission and review of oncology products among international regulatory partners, aiming to expedite patient access to innovative cancer treatments. It involves regulatory authorities from Australia, Canada, Singapore, Switzerland, Brazil and Israel. The UK’s regulatory authority for medicines, medical devise and blood components, the Medicines and Healthcare products Regulatory Agency (MHRA), became a full participant of Project Orbis as of 1 January 2021 after the EU transition period. The Project Orbis Partners may propose products for inclusion in the scheme, and each country remains fully independent on their final regulatory decision.

How does it work in the UK?

Applications submitted to the MHRA within a Project Orbis procedure must be new marketing authorisation applications (MAAs) or new indication applications for oncology products. From 1 January 2025 under the Windsor Framework, authorisations granted through the programme will be applicable UK-wide. The FDA coordinates product selection, and submissions must meet the FDA’s clinical criteria for priority review.

There are three different types of submission:

– Type A (Regular Orbis): Concurrent or near-concurrent submissions to the FDA and MHRA.
– Type B (Modified Orbis): Submissions with a delay greater than 30 days or regulatory action more than 3 months after the FDA.
– Type C (Written Report Only Orbis): FDA has already taken regulatory action, and the
FDA shares completed review documents with the MHRA.

Once a product or new indication has been identified for inclusion in Project Orbis, the FDA contacts the MHRA to request involvement. If the request is provisionally accepted, the parent US company provides details of the local affiliate to the MHRA. MHRA participation is contingent on agreement with the UK affiliate.

The relevant national authorisation fee for any applications made to Project Orbis will need to be paid.

Multidisciplinary assessment teams, including consultation with MHRA Expert Advisory Groups and the Commission on Human Medicines, will carry out the assessment.

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

Approval under Project Orbis

Many medicinal products have now been approved by the MHRA under Project Orbis. Some of these products are list below.

Osimertinib (Tagrisso)

The MHRA issued its first authorisation under Project Orbis for osimertinib, sold under the brand name Tagrisso (from AstraZeneca), in May 2021. Osimertinib is a post-surgery treatment for non-small cell lung cancer. Osimertinib is a tyrosine kinase inhibitor. It blocks the activity of EGFR, which normally controls the growth and division of cancer cells. Osimertinib is protected by a number of patents around the world, including by EP2736895B1. EP273689B1 relates to the compound: N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide: or a pharmaceutically acceptable salt thereof.

Belzutifan (Welireg)

The MHRA approved belzutifan, sold under the brand name Welireg (from Merck), under Project Orbis in May 2022. Belzutifan 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). Belzutifan inhibits the transcription factor hypoxia inducible factor 2 alpha (HIF-2α), which regulates cellular proliferation, angiogenesis and tumour growth. Belzutifan is protected by many patents worldwide, including EP3043784B1. EP3043784B1 relates to a compound of Formula III or a pharmaceutically acceptable salt thereof. The structure of belzutifan is specifically provided in the dependent claims: Tarlatamab (Imdelltra)

More recently, the MHRA approved the medicine tarlatamab, sold under the brand name Imdelltra (from Amgen), under Project Orbis in December 2024. Tarlatamab is a treatment for adult patients with small cell lung cancer (SCLC) that has spread throughout the lungs and/or to other parts of the body. Tarlatamab is a type of immunotherapy drug known as a bispecific T-cell engager. It works by binding to two proteins: CD3 on healthy T-cells and DLL3 on small cell lung cancer cells. This binding brings the T-cells and cancer cells close together, enabling the T-cells to more effectively recognize and kill the cancer cells. Tarlatamab is protected by many patents worldwide (see, for example, WO2017021349A1).

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