GSK brings Australian research discovery Omjjara (momelotinib) home: new treatment PBS listed for rare bone marrow cancer

  • Omjjara (momelotinib), discovered by Melbourne scientists in 2005, is now available on the PBS to treat the rare bone marrow cancer myelofibrosis.1,2 
  • This is the first time in almost a decade that eligible patients with this debilitating bone marrow cancer have an approved and PBS reimbursed new treatment option.1-3 
  • Myelofibrosis is diagnosed in around one in every 100,000 Australians.4 At diagnosis, nearly a quarter require regular blood transfusions.5,6 

 

GSK Australia is pleased to announce Omjjara (momelotinib) will be reimbursed on the Pharmaceutical Benefits Scheme (PBS) from April 1, 2025 for intermediate or high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in patients with moderate to severe anaemia and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.1,2** 

This PBS listing - which comes just four months after being approved for use in Australia by the Therapeutic Goods Administration (TGA) - makes local research discovery Omjjara the first approved and funded therapy for patients with myelofibrosis in almost a decade.1,2 

Omjjara was discovered by Melbourne scientists in 2005.1 It is a daily tablet used in adult patients who are JAK inhibitor naïve or who have been treated with ruxolitinib.7** 

It is one of only a handful of Australian drug discoveries to be approved for use in the United States of America and Australia and is now PBS funded.1,8-11 

Announcing the PBS reimbursement, Andrew Thomas, GSK VP & General Manager, Australia thanked the Federal Government and commented: “After being introduced internationally, we are thrilled to finally bring Omjjara ‘home’ and remain enormously proud of our contribution and of the teams who have made this happen. 

“PBS reimbursement of this important bone marrow cancer therapy recognises the high unmet need that exists for patients living with myelofibrosis and moderate to severe anaemia.** 

“We also acknowledge the award-winning Australian scientists whose original idea has now gone from ‘bench to bedside’,” Mr Thomas said. 

Myelofibrosis is diagnosed in around one in every 100,000 Australians, most commonly in those aged between 60 and 70.3  People who are diagnosed with this rare cancer have an average survival of 5-7 years,4 and almost a quarter are in need of regular blood transfusions at diagnosis.5 Within a year, up to 46% will experience anaemia.5,6 

The Melbourne scientists who developed Omjjara Professor Andrew Wilks and Dr Chris Burns, commented: “Today’s PBS milestone is our ‘full circle’ moment. Reimbursement of our invention Omjjara will now help to ensure it is available and accessible for all eligible patients living with this very challenging bone marrow cancer.  To see this achieved thirty years after it was invented is very gratifying.” 

Leukaemia Foundation CEO Chris Tanti also welcomed the PBS announcement: “Those living with myelofibrosis often have limited treatment options and their quality of life can be very much affected. Giving eligible Australian patients access to another treatment option is an important step forward.” 

Myelofibrosis can cause debilitating symptoms, including excessive night sweats, fever, itching, weight loss, fatigue, abdominal or bone pain.12,13 Patients often endure frequent blood transfusions, involving hospital visits, and constant monitoring.14  Individuals who are dependent on blood transfusions have a reduced quality of life and may have a poorer prognosis.15 

PBS approval of Omjjara is based on the results of two pivotal Phase III clinical studies SIMPLIFY-116 and MOMENTUM.17 The most common reported adverse reactions within the clinical studies included diarrhoea, thrombocytopenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain, and cough.7** 

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

ENDS

Cube Enquiries GSK Enquiries
Anne-Marie Sparrow Emma Power
0417 421 560 0419 149 525
anne-marie@cube.com.au emma.k.power@gsk.com

 

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. For more information see full Consumer Medicine Information: OMJJARA 

 

PBS information: OMJJARA has been listed on the PBS from April 1 2025 for intermediate or high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in patients with moderate to severe anaemia and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. 

Safety: Common side effects include diarrhoea, low platelets, nausea, headache, dizziness, fatigue, feeling weak, abdominal pain, rash and cough. Serious side effects include infections and a change in blood test results that may include - low blood platelet count (thrombocytopenia), low levels of a type of white blood cells (neutropenia), changes that may indicate signs of liver problems (alanine aminotransferase increased and aspartate aminotransferase increased). For a full list please refer to full Consumer Medicine Information. https://medsinfo.com.au/consumer-information/document/Omjjara_CMI 

Precautions: OMJJARA may make people feel dizzy or have blurred vision and therefore influence their ability to drive and use machines. People must observe caution when driving or using machines. 

Contraindications: Hypersensitivity to the active substances or to any component of the vaccine. 

Interactions: The following active substances need to be considered by a healthcare professional with someone receiving OMJJARA; rosuvastatin, carbamazepine, phenobarbital, phenytoin, St John’s wort. It is currently unknown if OMJJARA could reduce the effectiveness of oral or other contraceptives, therefore it is recommended a barrier method is used during treatment and for at least 1 week after taking the last dose of OMJJARA. For further information, please refer to the Consumer Medicine Information. https://medsinfo.com.au/consumer-information/document/Omjjara_CMI 

 

About GSK  

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Home | GSK AU 
 

About Myelofibrosis  

Myelofibrosis is a rare bone marrow cancer, diagnosed in around 1 in every 100,000 Australians and most commonly in those aged between 60 and 70.3   It can cause debilitating symptoms, including excessive night sweats, fever, itching, weight loss, fatigue, abdominal or bone pain. Myelofibrosis has an average survival of 5-7 years.4 Within a year of diagnosis, a significant proportion of those with the cancer become anaemic, and nearly a quarter are in need of regular blood transfusions often resulting in a reduced quality of life and a poorer prognosis.5,6 

 

References 

  1. Wilks et al. Mol Cell Biol 1991 10.1073/pnas.86.5.1603
  2. Pharmaceutical Benefits Advisory Committee. November 2024. Meeting Outcomes PBAC Meeting. Available: pbac-web-outcomes-11-2024.pdf Accessed March 2025.
  3. Pharmaceutical Benefits Scheme. 2017. Public Summary Document – November 2017 PBAC Meeting. Available: peginterferon-psd-november-2017.pdf Accessed February 2025.  
  4. Leukaemia Foundation. May 2024. Primary myelofibrosis Available: Primary myelofibrosis - Leukaemia Foundation. Accessed February 2025.
  5. Masarova et al. Cancer, April 2022. 10.1002/cncr.34103
  6. Tefferi A et al. Mayo Clinic Proceedings, 2012. 10.1016/j.mayocp.2011.11.001
  7. Omjjara Product Information, 2024.
  8. 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 February 2025.
  9. Australian Academy of Science. Relenza, 2024. Available: Mark von Itzstein | Australian Academy of Science Accessed February  2025
  10. Venetoclax (Venclexta). 27 July 2017. Available: Anti-cancer treatment yields up to US$325M in landmark Australian deal | WEHI Accessed February 2025.
  11. Australian Government. National Health and Medical Research Council. The University of Queensland, 2023. Available: Gardasil - the HPV vaccine: Case Study. Accessed March 2025.
  12. Mesa et al. Blood, 2008. 10.1182/blood.V112.11.1754.1754
  13. Mesa et al. Cancer, 2006. https://doi.org/10.1002/cncr.22365
  14. Leukaemia & Lymphoma Society MPN Booklet_2021. Available: https://www.lls.org/sites/default/files/2021-10/PS81_MPN_Booklet_2021.pdf Accessed February 2025
  15. Elena et al. Haematologica, 2010. https://doi.org/10.3324/haematol.2010.031831
  16. Mesa et al. J Clin Oncol, 2017. 10.1200/JCO.2017.73.4418
  17. Verstovsek et al. The Lancet, 2023. 1016/S0140-6736(22)02036-0

 

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