Project Orbis was initiated on 17 September 2019 by the US FDA to provide a framework for the concurrent submission and review of innovative oncology products among international regulatory authorities. The focus of the initiative is on high impact cancer treatments targeting unmet needs or providing significant benefit over existing therapies. The agencies participating in Project Orbis include Australia (TGA), Canada (Health Canada), the UK (MHRA), Japan (PDMA), Singapore (HSA) and Brazil (ANVISA).
This list continues to expand. By participating in Project Orbis, other regulatory authorities can benefit by sharing information and collaborating so that treatments can receive speedier approvals in countries other than the US. All participation is voluntary and there are no requirements that labeling or indications must match between the authorities. In the first 12 months of the project, 38 approvals were granted from multiple regulatory authorities.
Origins and evolution
Regulatory harmonisation is an ongoing need for regulatory and health authorities worldwide. The more harmonised regulations are around clinical trials, patient experience and application requirements, the closer the world moves towards an agreed-upon standard of care. At the same time, there are so many global initiatives based on topics, regions and standards that it can be difficult to know where to begin. In looking for a focus, regulatory authorities are agreed that oncology is where collaboration between regulatory authorities can provide significant rewards in having approved therapeutics get to market faster without sacrificing safety or efficacy.
The US FDA is frequently the recipient of new oncology product applications ahead of other regulatory authorities. Starting in 2004, in the spirit of collaboration, the US FDA’s Office of Hematology and Oncology Products (OHOP) began holding regularly scheduled teleconferences with other regulatory authorities to discuss and exchange information on oncology products under review. Regulatory authorities with mutual confidentiality agreements are part of the discussions. They currently include Australia’s TGA, Canada’s Health Canada, EU’s EMA, Japan’s PMDA and Switzerland’s Swissmedic.[1]
Project Orbis is an initiative of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities.[1] Project Orbis was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. The US FDA hoped to help speed review in other countries without slowing down the US FDAs review.
For this project, pharmaceutical companies are asked to submit applications for clinically significant oncologic products to participating countries at the same time for concurrent review by their regulatory authorities. All participation by sponsors and regulatory authorities is voluntary. All applications must meet the US FDA’s Priority Review Designation criteria in order to be considered for Project Orbis. Some requirements for participating regulatory authorities are to have a confidentiality agreement in place with the other Project Orbis participants and the availability to participate in both general and application-specific meetings.[2]
Candidate applications can be identified by either the US FDA or the US sponsor with a submission plan being submitted by the sponsor. The FDA would then share the plan with other Project Orbis partners to confirm interest and availability. Each regulatory authority retains full ownership of what regulatory action is taken and what language would go into product labelling.[3] Due to the fact that Project Orbis is not a work-sharing initiative, approved indications may be different by a few words or exactly the same between participating countries.
Project Orbis focused rst on supplemental oncology approvals (new indications for previously approved therapies) and then moved to allow initial marketing applications into the project after 2 supplemental approvals.
Types of Project Orbis submissions
There are three types of Project Orbis submissions defined[4] , based on how concurrent the reviews will be handled by the participating regulatory authorities:
Type A, also known as ‘Regular’
Applications will be submitted concurrently or near-concurrently (within 30 days) to the US FDA and any other participating regulatory authorities. This allows for concurrent review and possible concurrent regulatory action.
Type B, also known as ‘Modified’
Applications submitted with a greater than 30-day delay or a regulatory action greater than three months of the FDA action. Allows for some concurrent review with the US FDA but no concurrent action.
Type C, also known as ‘Written Report Only’
The US FDA has already taken regulatory action and will share their completed review documents with other identi ed regulatory authorities but there will be no concurrent review or action with the US FDA.
Table 1:Regulatory authorities participating in Project Orbis
| Regulatory authority | Involvement |
|---|---|
| Australia – TGA | Initial partner – May 2019 [1] |
| Brazil – ANVISA | Agreed to participate in May 2020 [11] |
| Canada – Health Canada | Initial partner – May 2019 [1] |
| Singapore – HSA | Agreed to participate in October 2019 [12] |
| Switzerland – Swissmedic |
Agreed to participate in March 2020 as a pilot[13] Announced permanent participation in February 2021[14] |
| UK - MHRA | Announced full participation as of 1 Jan 2021[15] |
| US - FDA | Initial partner - May 2019 [1] |
First approval via Project Orbis
On 17 Sep 2019, the US FDA announced that accelerated approval was granted to a supplement for Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma.[5] Australia’s TGA[6] and Canada’s Health Canada[7] participated and approvals for supplements followed within days from the three agencies. The review by the US FDA also utilised the OCE’s Real-Time Oncology Review (RTOR) pilot program[8] (see Box 1).
The signi cance of the supplement approval was due to it being the first US approval for an anti-PD-1 therapy used in combination with a kinase inhibitor for advanced endometrial cancer in the US[9] , which is why it was reviewed under the RTOR program. In July 2021, full approval was received by the US FDA based on the verification of clinical benefit which followed on the accelerated approval in 2019[10]. Project Orbis has now expanded well beyond the first US approval to multiple Regulatory Authorities (see Table 1).
Summary of the first year of Project Orbis
The US FDA disclosed the numbers of applications and approvals for the first year of Project Orbis (June 2019 through June 2020) in December 2020 after analysis.[11] In the first year, 60 applications in total across all involved regulatory authorities were received, and those applications resulted in 38 total approvals across those regulatory authorities. The FDA provided a breakdown in their analysis of the cancer types most represented in the applications (see Figure 1). Efficacy supplements formed the majority of Project Orbis applications (72%), with the remainder being new molecular entities.[16] Official comments on Project Orbis from Australia’s TGA, Health Canada and Swissmedic are positive in nature, with a special focus on appreciation for the increased inter-agency collaboration that provides the steppingstones to improved regulatory harmonisation.[12]
Confidentiality agreements must be in place between participating agencies, but even so there are situations where information may be redacted before being shared. In at least one review, Australia’s TGA made the comment that in some cases it was difficult to review documentation because so much information had been redacted. Notably, the third regulatory action taken as part of Project Orbis was the US FDA approval of a new molecular entity, Tukysa (tucatinib) for HER2-positive breast cancer.[17] The initiative was started with a focus on supplemental applications since major reviews for the initial approval would have already occurred and it kept the scope of the reviews in check. However, with the success of the first two reviews, Project Orbis quickly expanded to new molecular entities. Approvals from other participating regulatory authorities were not exactly simultaneous, but were a significant improvement in the usual timeline, starting a month after the US FDA’s approval and continuing through the months following, Swissmedic, the Singapore HSA, Health Canada and Australia granted approvals.
| Drug name | Regulatory authorities | Details |
|---|---|---|
| Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) |
US FDA – Supplement approved 17 Sep 2019[5] Australia TGA – Supplement provisionally approved 18 Sep 2019[18] Health Canada – Supplement conditionally approved 20 Sep 2019[7] |
US FDA Indication: Treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. |
| Calquence (acalabrutinib) |
US FDA – Supplement approved 21 Nov 2019[19] Health Canada – Supplement approved 21 Nov 2019[7] Australia TGA – Supplement provisionally approved 25 Nov 2019[20] |
US FDA Indication: Treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| Tukysa (tucatinib): in combination with the chemotherapy drugs trastuzumab and capecitabine |
US FDA – Approved 17 Apr 2020[17] Swissmedic – Approved 07 May 2020[21] Singapore HSA – Approved 19 May 2020[22] Health Canada – Approved 03 Jun 2020[23] Australia TGA – Approved 13 Aug 2020[24] UK MHRA – Approved 23 Feb 2021[25] |
US FDA Indication: In combination with the chemotherapy drugs trastuzumab and capecitabine for the treatment of adults with advanced forms of HER2-positive breast cancer that cannot be removed with surgery, or has spread to other parts of the body, and who have received one or more previous treatments. |
| Imbruvica (ibrutinib) plus rituxmab |
US FDA – Supplement approved 21 Apr 2020[26]) Health Canada – Supplement approved 13 Jan 2021[27] |
US FDA Indication: First-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| Qinlock (ripretinib) |
US FDA – Approved 15 May 2020[28] Health Canada –Approved 22 Jun 2020[29] Australia TGA – Approved 13 Jul 2020[30] |
US FDA Indication: Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. |
| Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy |
US FDA – Supplement approved 26 May 2020[31] Health Canada – Supplement approved 11 Aug 2020[32] |
US FDA Indication: First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. |
| TECENTRIQ (atezolizumab) in combination with AVASTIN (bevacizumab) |
US FDA – Supplement approved 29 May 2020[33] Health Canada – Approved 19 Aug 2020[34] |
US FDA Indication: For patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Health Canada Indication: Minor text differences from US FDA. |
| ZEPZELCA (lurbinectedin) |
US FDA – Approved 15 Jun 2020[35] Australia TGA: Approved 10 Sep 2021[36] |
US FDA Indication: Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| Inqovi (decitabine and cedazuridine) |
US FDA – Approved 07 Jul 2020[37] Health Canada – Approved 08 Oct 2020[38] Australia TGA – Approved 02 Nov 2020[39] |
US Indication: Treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. |
| Venclexta (venetoclax) |
US FDA – Approved 16 Oct 2020[40] Health Canada – Approved 15 Dec 2020[41] |
US FDA Indication: In combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. |
| Tagrisso (osimertinib) |
US FDA – Supplement approved 18 Dec 2020[42] UK MHRA – Extension approved 07 May 2021[43] |
US FDA Indication: For adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
| TEPMETKO® (tepotinib) | US FDA – Approved 03 Feb 2021[44] | US FDA Indication: For adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations. |
| Trodelvy (sacituzumab govitecan) |
US FDA – Approved 07 Apr 2021[45] Australia TGA – Approved 14 Sep 2021[46] Health Canada – Approved 28 Sep 2021[47] |
US FDA Indication: For patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. |
| Truseltiq (infingratinib) | US FDA – Approved 28 May 2021[48] | US FDA Indication: Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. |
| Lumakras (sotorasib) |
US FDA – Approved 28 May 2021[49] UK MHRA – Conditional approval 10 Sep 2021[50] |
US FDA Indication: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDAapproved test, who have received at least one prior systemic therapy. |
| Rezurock (belumosudil) | US FDA – Approved 16 Jul 2021[51] | US FDA Indication: Treatment of adult and pediatric patients 12 years and older with chronic graft -versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. |
| Welireg (belzutifan) | US FDA – Approved 13 Aug 2021[52] | US FDA Indication: Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery |
The future of Project Orbis
The first year of Project Orbis was considered a success by the US FDA, with additional regulatory authorities joining and a large number of supplements and new molecular entities going through the process. The UK MHRA made joining the project one of its earliest actions upon removal from the EU’s EMA.[15] In its International Engagement Strategy 2021-2025, Australia’s TGA has stated it will continue to participate in the project[53] and Swissmedic has also committed to permanent membership and created relevant guidance.[14] Industry coalitions such as the Bloomberg International Cancer Coalition, which aims to foster international clinical trial collaboration, will also increase involvement by working with regulators to improve and harmonize the framework for oncology drugs.[54]
As more regulatory authorities join the initiative, sponsors will bear the burden of understanding how Project Orbis could overlap or be supported by other global regulatory harmonization initiatives and accelerated review projects specific to each agency. A prime example of this is the Parallel Review Shared-Space Use Case being worked on by Accumulus Synergy, a non-profit building a global data exchange.[55] The Parallel Review use case is closely based on the type of collaborative review used in Project Orbis which allows data exchange between sponsors and regulators for a faster and safety review process.
References
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[4] UK MHRA. Types of Project Orbis submissions. 10 December 2020. Available at: Project Orbis - GOV.UK (www.gov.uk) (accessed 19 November 2021).
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[6] Australia TGA. Provisional application receives approval through the first international collaborative review initiative between TGA, FDA and HC. 18 September 2019. Available at:Provisional application receives approval through the first international collaborative review initiative between TGA, FDA and HC | Therapeutic Goods Administration (TGA) (accessed 19 November 2021).
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[27] Janssen. Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia. 13 Jan 2021. Available at: Janssen Announces Health Canada Approval of IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab for Treatment-Naïve Patie - Bloomberg (accessed 19 November 2021).
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[31] Bristol-Myers Squibb. U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%. 15 May 2020. Available at: Bristol Myers Squibb - U.S. Food and Drug Administration Approves Opdivo® (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer (bms.com) (accessed 19 November 2021).
[32] Bristol-Myers Squibb. Health Canada Approves OPDIVO(nivolumab) plus YERVOY (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer. 11 August 2020. Available at: Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer (newswire.ca) (accessed 19 November 2021).
[33] US FDA. FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma. 01 Jun 2020. Available at: FDA Approves Atezolizumab Plus Bevacizumab for Unresectable (esmo.org) (accessed 19 November 2021).
[34] FirstWordPharma. Health Canada grants market authorization for Tecentriq in combination with bevacizumab,[1] the first immunotherapy combination treatment, for the most common form of liver cancer. 19 August 2020. Available at: https:// old.firstwordpharma.com/node/1750413?tsid=17 (accessed 19 November 2021).
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[48] US FDA. FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma. 28 May 2021. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-infigratinibmetastatic-cholangiocarcinoma (accessed 19 November 2021).
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