Incyte secured Australian registration for its antibody‑based therapy Minjuvi (tafasitamab) for the treatment of adult patients with relapsed or refractory follicular lymphoma in combination with rituximab and lenalidomide, effective immediately.
The approval follows the Phase 3 inMIND study, which demonstrated a median progression‑free survival of 22.4 months for the Minjuvi combination versus 13.9 months in the control arm, representing a 57% reduction in the risk of disease progression, relapse, or death.
Minjuvi is the first and only chemotherapy‑free CD19 and CD20 dual‑targeted immunotherapy combination approved in Australia for this indication, addressing an unmet need for the approximately 1,500 new follicular lymphoma cases diagnosed annually in the country.
The distribution partnership with Specialised Therapeutics, established in 2021, will commercialize Minjuvi in Australia, New Zealand, and Singapore; the drug is not yet listed on the Australian Pharmaceutical Benefits Scheme, but the partner is working to enable patient access.
For Incyte, the approval expands its oncology portfolio beyond its core myelofibrosis product Jakafi, aligning with the company’s strategy to diversify revenue streams. The new market is expected to contribute to the 2026 non‑Jakafi revenue guidance of $4.77 billion to $4.94 billion and to the Hematology & Oncology segment revenue forecast of $800 million to $880 million.
CEO Bill Meury highlighted Incyte’s momentum and pipeline progress, noting that regulatory approvals are part of the company’s 2026 strategy to strengthen its portfolio and drive long‑term growth.
Analysts maintain a moderate buy consensus for Incyte; no immediate market reaction to the Australian approval has been identified.
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