TGA gives green light to GSK-acquired Australian drug for bone marrow cancer

Australians living with myelofibrosis, a rare bone marrow cancer, now have access to the first treatment specifically approved for those with moderate to severe anaemia.

The Therapeutic Goods Administration (TGA) has given the green light to Omjjara (momelotinib), a once-daily oral therapy for patients who are Janus kinase (JAK) inhibitor-naïve or previously treated with Novartis’ Jakafi (ruxolitinib).

This milestone represents the culmination of a remarkable 30-year journey that began in Melbourne in the 1980s. The discovery of JAK proteins and the development of Omjjara originated with local scientists Professor Andrew Wilks and Dr Chris Burns at the Walter and Eliza Hall Institute of Medical Research. Their pioneering work has been recognised with the prestigious Prime Minister’s Prize for Innovation.

“We are incredibly proud to have secured TGA approval for this significant local scientific discovery,” said Andrew Thomas, GSK Vice President and General Manager for 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 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, Professors Wilks and Dr Burns shared their excitement about the milestone, saying “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.”

Omjjara’s approval was based on the results of two pivotal Phase III clinical trials, SIMPLIFY-1 and MOMENTUM.

“The TGA approval of Omjjara introduces an important new option for those with myelofibrosis and moderate to severe anaemia,” said Professor Andrew Perkins, Professor of Haematology at The Alfred Hospital, Melbourne, and Head of Genomic Medicine, Alfred Health.

“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.”

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

Myelofibrosis is diagnosed in approximately one in every 100,000 Australians, most commonly affecting people aged 60-70. The disease presents a challenging prognosis, with an average survival of 5-7 years. Nearly a quarter of patients require regular blood transfusions, and within a year, up to 58% will experience anaemia.

GSK acquired Omjjara in 2022 and has since secured regulatory approvals in the US, Europe, and now Australia. This makes Omjjara one of a select few original Australian research discoveries to achieve both TGA and FDA approval, reinforcing the importance of fostering local medical innovation.

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