Local scientific discovery Omjarra (momelotinib) now TGA approved for Australians with rare bone marrow cancer

Embargoed: 06.00am Thursday 16^th January 2025, MELBOURNE, AUSTRALIA

• Omjjara (momelotinib) was discovered by Melbourne scientists in 2005.¹
• Today’s TGA approval follows its recent FDA approval and makes it one of only a handful of original Australian scientific discoveries to secure both milestones.^1-6
• Omjjara is a once daily pill indicated to treat disease-related consequences of primary or secondary myelofibrosis including spleen enlargement and moderate to severe anaemia.⁷
• Myelofibrosis is a rare bone marrow cancer with an average survival of 5-7 years.^7-8

GSK Australia welcomes the Therapeutic Goods Administration (TGA) approval of Omjjara - a local scientific discovery now providing the first treatment indicated for Australians living with the rare bone marrow cancer myelofibrosis and who have moderate to severe anaemia.⁷

Omjjara is a once daily pill that will be used in adult patients who are Janus kinase (JAK) inhibitor naïve or who have been treated with ruxolitinib.⁷

This TGA approval is the culmination of a thirty-year research story that began in Parkville, Melbourne in the 1980s, with scientists Professor Andrew Wilks and Dr Chris Burns discovering the Janus kinase (JAK) proteinsand the compound moMELotinib, named after its research home.¹

Myelofibrosis is diagnosed in around one in every 100,000 Australians and most commonly in those aged between 60 and 70.⁹   People who are diagnosed with myelofibrosis have an average survival of 5-7 years,⁸ and nearly a quarter are in need of regular blood transfusions.¹⁰ Within a year, up to 58% will experience anaemia.¹⁰

GSK acquired Omjjara in 2022 and has secured regulatory approvals in the US, Europe and now Australia to bring it to the patient community.  Omjjara becomes just one of only a handful of original local research discoveries to secure both TGA and US FDA approval.^1-6

Omjjara is known as a protein kinase inhibitor and works by blocking the action of key proteins associated with the disease.⁷

“We are incredibly proud to have secured TGA approval for this significant local scientific discovery,” says Andrew Thomas, GSK VP & General Manager, Australia, Greater China and Intercontinental.  “This is a key step to making it available for those living with this challenging bone marrow cancer.

“We applaud the work of Professor Wilks and Dr Chris Burns, who discovered this molecule. Our commitment now is to support the delivery of Omjjara to the patient community, and to highlight the importance of continued investment into Australian medical research.”

In a joint statement, Professor Andrew Wilks and Dr Chris Burns, comment: “We are so proud to see momelotinib achieve TGA approval. This milestone allows us to bring this molecule home to Australia, and to Melbourne. Every scientist dreams of taking their development from ‘bench to bedside’ and we are grateful to GSK for now ensuring our science will do what we set out to achieve with our team’s research efforts – bring momelotinib to those living with myelofibrosis."

Myelofibrosis can cause debilitating symptoms, including excessive night sweats, fever, itching, weight loss, fatigue, abdominal or bone pain.^11-12   Patients often endure frequent blood transfusions, involving hospital visits, and constant monitoring.¹³ Individuals who are dependent on blood transfusions have a reduced quality of life and may have a poorer prognosis.¹⁴

TGA approval of Omjjara is based on the results of two pivotal Phase III clinical studies SIMPLIFY-1¹⁵ and MOMENTUM.¹⁶ The most common reported adverse reactions within the clinical studies included diarrhoea, thrombocytopenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain, and cough.⁷

“The TGA approval of Omjjara introduces an important new option for those with myelofibrosis with moderate to severe anaemia. This cancer can have a profound impact on a person’s overall health and quality of life. The disease can be overwhelming, with fatigue, and other debilitating symptoms,” states Prof. Andrew Perkins, Professor of Haematology at The Alfred Hospital, Melbourne and Head of Genomic Medicine, Alfred Health.

“Myelofibrosis is a rare bone marrow cancer where patients have faced a difficult prognosis with limited treatment choices,” adds Ken Young, founding member of the MPN Alliance Australia team. “We hear many stories of lives being uprooted to manage hospital visits for blood transfusions and monitoring.”

GSK is committed to working with key stakeholders in order to provide equitable access for patients living with myelofibrosis.

Patients should speak to their physician or haematologist for guidance on the management of their condition.

Ends

Visual Story Assets:

Dropbox: Omjjara Momelotinib TGA Consumer Media Visual Files_Embargoed 16 January 2025  

Footnote

*Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

About GSK

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References

1. ABC News. PM Awards in Science & Innovation. 8 October 2024. Available: Astrophysicist Matthew Bailes wins 2024 Prime Minister's Prize for Science Accessed October 2024.
2. Therapeutic Goods Administration. ARTG entry for product ID 442232. Available: https://www.tga.gov.au/resources/artg/442232 Accessed December 2024.
3. Liam Mannix, The Age and Sydney Morning Herald.19 September 2023. Australian-made cancer drug gets billion-dollar US FDA approval. Available: https://www.smh.com.au/national/australian-made-cancer-drug-gets-billion-dollar-us-fda-approval-20230918-p5e5gp.html Accessed September 2024.
4. Australian Academy of Science. Relenza, 2024. Available: Mark von Itzstein | Australian Academy of Science Accessed September 2024.
5. Venetoclax (Venclexta). 27 July 2017. Available: Anti-cancer treatment yields up to US$325M in landmark Australian deal | WEHI Accessed October 2024.
6. Translational Research Institute Australia - Cervical cancer | Translational Research Institute Accessed October 2024.
7. Omjjara Consumer Medicine Information
8. Masarova et al. Cancer April 2022
9. Leukaemia Foundation. 2023. Primary myelofibrosis.
10. Tefferi, A.,et al. 2012. One thousand patients with primary myelofibrosis: The Mayo Clinic experience.
11. Mesa et al., 2008. Assessment-and-Monitoring-of-Constitutional-Symptoms-in-Patients-with-myelofibrosis
12. Mesa et al., 2006. The Burden of Fatigue and Quality of Life in Myeloproliferative Disorders (MPDs)
13. Leukaemia & Lymphoma Society MPN Booklet_2021. Available: https://www.lls.org/sites/default/files/2021-10/PS81_MPN_Booklet_2021.pdf Accessed September 2024.
14. Elena et al., 2010. Red Blood Cell transfusion-dependency implies a poor survival in primary myelofibrosis irrespective of IPSS and DIPSS
15. Mesa et al J Clin Oncol 2017 Dec 1;35(34):3844-3850
16. Verstovsek et al, The Lancet, January 28, 2023. Available: Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study - The Lancet Accessed September 2024.

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NP-AU-MML-PRSR-240002. Date of Preparation: December 2024

Media contacts:

Cube: Anne-Marie Sparrow on 0417 421 560 / anne-marie@cube.com.au

GSK: Emma Power on 0419 149 525/ emma.k.power@gsk.com