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News & Trends - Pharmaceuticals

Novartis secures PBS listing of first JAK1/2 inhibitor for serious complication of stem cell transplants

Health Industry Hub | April 12, 2023 |

Graft-versus-host disease (GvHD) is a serious and debilitating complication of stem cell transplants, with no established standard of care for patients, who do not adequately respond to first-line steroid treatment. Nearly half of patients, who undergo allogeneic transplants experience either acute or chronic GvHD, or both.

Pharma company, Novartis, announced the listing of oral therapy Jakavi (ruxolitinib) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients aged 12 years and older affected by acute or chronic graft versus host disease (GvHD), who have inadequate response to corticosteroids or other systemic treatments.

“An allogeneic transplant is a lifesaving treatment for many patients with blood disorders including cancers. However, graft versus host disease (GVHD), is a challenging complication that has profound impacts on patients’ quality-of-life and can have fatal consequences. The standard approach is to use high dose steroids which can have serious side effects especially if used long term. Many patients either don’t respond to steroids or are unable to tolerate them for extended periods of time. It is exciting that we now have a new standard of care to offer these patients. Patients living with graft versus host disease are survivors of a long and complicated diagnosis and treatment journey. It is a privilege to be able to offer them this advancement in GVHD treatment,” Associate Professor Hamad said.

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Jakavi is the first JAK1/2 inhibitor available in Australia for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease (GvHD) who have inadequate response to corticosteroids or other systemic treatments. To date, over 300 patients in Australia have accessed JAKAVI for the treatment of GvHD through clinical trials or access programs.

A recent systemic review and meta-analysis involving 1358 patients on Jakavi showed that survival rates were 57.5% and 80.3% for acute GVHD (aGVHD) and chronic GVHD (cGVHD), respectively. The overall response was 74.9% in aGVHD and 73.1% in cGVHD.

“As someone who lost their partner to GvHD, I have seen just how devastating this disease can be. I cannot express how grateful I am to have new medications such as Jakavi to treat people who have had a donor stem cell transplant. GvHD is an incredibly common side effect, affecting over 50% of all transplant patients where donor stem cells are used, so to read such positive stories from patients about their quality of life after being treated with Jakavi is something which gives hope to so many,” said Neil Pennock, Founding Director, TLR Foundation.

“Time is of the essence for patients living with acute and chronic Graft versus Host disease (GvHD) and their caregivers, who have had no other, or limited, treatment options until now. Globally, little progress has been made over the past 30 years in developing a treatment for GvHD. We are excited to be able to bring Jakavi to people living with GvHD in Australia,” said Richard Tew, Country President Novartis Australia, and New Zealand.

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