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PBAC considering selinexor for a third time

For the third time, selinexor (Xpovio®) will be considered by the Pharmaceutical Benefits Advisory Committee (PBAC) at its November 2022 meeting for the treatment of relapsed/refractory (R/R) myeloma.

Selinexor illustrationThe sponsor, Antengene, had previously, and unsuccessfully, sought a PBAC recommendation – initially in July 2021, and again in March 2022, for selinexor used in combination with bortezomib (Velcade®) and dexamethasone, for the treatment of R/R myeloma in patients who had received at least one prior therapy. 

The Leukaemia Foundation, which previously provided consumer comments in relation to the sponsor’s submission at both the July 2021 and March 2022 meetings of the PBAC, is again supporting the resubmission of selinexor in November.

Head of Research, Policy and Advocacy at the Leukaemia Foundation, Dr Peter Diamond said selinexor is a relatively new class of novel therapy.

“The results of a recent clinical trial indicate selinexor has high response rates with low rates of peripheral neuropathy,” said Dr Diamond.  

“Access to novel therapies is critical for patients who have failed second and subsequent lines of therapy. At this stage of disease, these therapies are not necessarily intended to be curative, but they can provide significant extensions to life. 

“Ensuring that extended life is as high quality as possible is also important,” he said. 

“Advances in therapies such as selinexor, which can provide significant progression-free survival with a lower toxicity profile than existing treatments, should be a priority for consideration by the PBAC.

“Given the high unmet need for therapies for patients with relapsed and/or refractory myeloma, the acceptable safety profile of this therapy, and the evidence of overall survival benefit, the Leukaemia Foundation urges the PBAC to recommend that this treatment is listed on the PBS for eligible patients,” said Dr Diamond.

Selinexor now available on the PBS for triple class refractory/penta-refractory myeloma

At the July 2021 meeting selinexor was also considered by the PBAC for a different indication – triple class refractory/penta-refractory myeloma in combination with dexamethasone for adults with R/R myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

While the initial submission was not recommended in July, it was recommended by the PBAC in March 2022, and selinexor for triple class refractory/penta-refractory myeloma was listed on the PBS from 1 September 2022.