The Australian Therapeutic Goods Administration (TGA) has granted provisional approval for Specialised Therapeutics’ Minjuvi (tafasitamab) regimen for treating diffuse large B-cell lymphoma (DLBCL) in adult patients.

The regimen comprises Minjuvi plus lenalidomide followed by Minjuvi monotherapy. This treatment is indicated for usage in adult relapsed or refractory DLBCL patients who are not candidates for autologous stem cell transplant.

An immunotherapy that targets CD19, Minjuvi acts by binding to a protein on the B-cell lymphoma cell surface, inducing an immune response against the condition.

It has already received approval in the UK, Canada, the US and Europe.

The latest development was based on findings from the multicentre, single-arm, open-label Phase II L-MIND study, which assessed the safety and efficacy of Minjuvi plus lenalidomide in relapsed or refractory DLBCL patients.

Further approval is contingent on validating and describing the regimen’s clinical benefit in the Phase III frontMIND study, which has concluded subject enrolment.

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Minjuvi is marketed by the company under an exclusive supply arrangement with Incyte.

Specialised Therapeutics CEO Carlo Montagner stated that securing TGA approval was a key regulatory milestone for the company.

“We are delighted to successfully register Minjuvi for Australian patients and look forward to working with the lymphoma.”

In September 2022, the Australian TGA provisionally approved Specialised Therapeutics’ Pemazyre (pemigatinib) to treat cholangiocarcinoma.