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FDA fast-tracks review of Incyte’s Jakafi for chronic GVHD

Submission is based on results from the pivotal REACH3 study

The US Food and Drug Administration (FDA) has awarded Incyte’s Jakafi a priority review for the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in patients aged 12 years and older.

GVHD is a condition that can occur after an allogeneic transplant, wherein the donated cells – often donated marrow or stem cells – react with a person’s normal cells, causing a range of symptoms. This includes diarrhoea, skin rashes and liver damage.

The reaction occurs when T cells in the donated bone marrow/stem cells attack the body’s cells, because the donated cells see the host cells as foreign.

The supplemental new drug application (sNDA) is based on results from the phase 3 REACH3 study, which compared Jakafi (ruxolitinib) to best available therapy (BAT) in patients with steroid-refractory chronic GVHD.

In this trial, Jakafi-treated patients experienced significantly greater overall response rates (ORR) compared to BAT at week 24.

In addition, Jakafi was also associated with a longer median failure-free survival (FFS) compared to  BAT at week 24, as well as greater symptom improvement, as measured by the modified Lee Symptom Scale (mLSS) at week 24.

The best ORR for patients receiving Jakafi treatment was 76.4%, and adverse events in this trial were consistent with the known safety profile for the drug.

With a priority review in hand, the review of Jakafi in chronic GVHD is shortened to six months, compared to ten months for a standard review.

A decision on the JAK1/2 inhibitor is expected by 22 June 2021, Incyte said in a statement.

“The acceptance of this sNDA represents an important milestone for Incyte as we continue our work towards helping more people living with GVHD, particularly for those who do not respond to steroids,” said Peter Langmuir, group vice president, oncology targeted therapies, Incyte.

Jakafi is already on the market as a treatment for acute GVHD in adult and children 12 years of age and older, whose disease has not improved after taking corticosteroids.

Outside the US, Swiss pharma company Novartis markets the drug as Jakavi. It is approved across a number of indications, including for the treatment of polycythemia vera (PV), intermediate- or high-risk myelofibrosis (MF) and post-essential thrombocythemia MF.

Last year, Novartis and Inctye also attempted to extend Jakafi’s reach into COVID-19, with a phase 3 study investigating whether the drug could be used as a treatment for COVID-19 associated cytokine storm.

However, the JAK inhibitor plus standard-of-care failed to prevent complications in this patient group in the RUXCOVID study.

In this trial, the number of patients who died or required mechanical ventilation due to respiratory failure or ICU care by day 29 was 12% for Jakafi-treated patients and 11.8% for the placebo group.

Article by
Lucy Parsons

24th February 2021

From: Regulatory

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