TAFASITAMAB

The PBAC recommended the PBS listing of tafasitamab for use in combination with lenalidomide and rituximab for the treatment of patients with relapsed or refractory follicular lymphoma (FL). In November 2025, the PBAC was of a mind to recommend tafasitamab but deferred its decision as the Therapeutics Goods Administration had not yet approved the medicine.  At its March 2026 meeting, the PBAC made its recommendation noting that the TGA has since supported the registration of tafasitamab in Australia. 
 
The PBAC noted previous input from health care professionals and organisations. It acknowledged the unmet needs for patients with FL, particularly those who are not fit for or unable to access stem cell transplantation.
 
While there were no head-to-head trials, the PBAC noted it has previously accepted that tafasitamab was more effective than rituximab-based chemotherapy at improving progression-free survival (the length of time that patients lived without their cancer progressing after treatment). However, the evidence in the submission did not allow confidence about the extent to which these outcomes would be realised in Australia. The tafasitamab trial included treatment with lenalidomide and rituximab in place of rituximab-based chemotherapy in the tafasitamab and control arms of the study. Rituximab-based chemotherapy is standard of care in Australian clinical practice. Also, the trial results did not clearly show that tafasitamab was better at improving overall survival (length of time that patients remained alive after starting treatment). The PBAC considered that tafasitamab (with lenalidomide and rituximab) was less safe than rituximab-based chemotherapy. 
 
The PBAC considered that the benefits claimed by the sponsor to justify its requested price were too optimistic, particularly its estimates of the increase in survival. The PBAC considered that a reduced price that reflected more realistic estimates of benefits would be acceptable. The PBAC considered the overall cost to the public to be overestimated and advised that adjustments were required in estimating a more accurate cost. 
 
The PBAC considered a risk-sharing arrangement was required to address any residual uncertainty regarding the estimated patient numbers. 
 
The PBAC noted that listing tafasitamab for use in combination with lenalidomide and rituximab would require a Section 100 Highly Specialised Drug Program Authority Required (Telephone/Online) listing of lenalidomide to enable use in combination with tafasitamab.