Specialised Therapeutics expands oncology footprint with two new medicines for ANZ

Specialised Therapeutics (ST) is expanding its alliance with Incyte Biosciences, signing an extended supply and distribution deal that will bring two additional oncology medicines to patients in Australia, New Zealand and Singapore.

The agreement builds on the companies’ existing partnership, which already covers the commercialisation of Minjuvi (tafasitamab) and Pemazyre (pemigatinib). Under the expanded arrangement, ST will now oversee the regional rollout of Niktimvo (axatilimab) and Zynyz (retifanlimab). Both drugs are slated for local regulatory and reimbursement submissions in 2025.

“Specialised Therapeutics has partnered with Incyte since 2021 and we are delighted to be extending this successful partnership,” said ST CEO Carlo Montagner.

“As part of our initial agreement, our teams have worked collaboratively to commercialise Minjuvi, which has been approved for use in Australia, and Pemazyre, which has been approved in Australia and Singapore, and we look forward to expanding the portfolio to help more patients with rare and hard-to-treat conditions.”

Niktimvo is a first-in-class CSF-1R-blocking antibody, recently approved by the US FDA (August 2024) to treat adults and children with chronic graft-versus-host disease (GVHD) who have failed at least two prior lines of systemic therapy. The drug’s novel mechanism positions it as a critical option for patients facing limited treatment choices.

Zynyz, an intravenous PD-1 inhibitor, has also secured US regulatory approval in combination with platinum-based chemotherapy for first-line treatment of adult patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC), as well as a monotherapy for those with progression or intolerance to platinum therapy.

Beyond SCAC, Zynyz is approved in both the US and Europe for patients with metastatic or recurrent Merkel cell carcinoma (MCC), a particularly relevant indication given that Australia has the world’s highest incidence of MCC. The therapy is also under active investigation in non-small cell lung cancer (NSCLC) and other solid tumour settings.

“ST has already demonstrated its ability to navigate complex regional regulatory pathways for Minjuvi and Pemazyre, and we look forward to continuing our work together to make these new therapies available for the oncology community in the Asia-Pacific region,” said Incyte CEO Hervé Hoppenot.

“The expanded partnership agreement reflected the synergies between the two companies, with a shared goal of improving outcomes for patients with unmet medical needs.”

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