New PBS listings recommended for acalabrutinib, elotuzumab and ravulizumab


The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended PBS listings for several treatments for patients with haematological cancers and haemoglobinuria.

At its July meeting the PBAC recommended the listing of acalabrutinib (Calquence) for people with relapsed and/or refractory mantle cell lymphoma (R/R MCL) who have received at least one prior therapy and have a WHO performance status of 0 or 1.

The PBAC considered that acalabrutinib should be available to BTK inhibitor-naïve patients or patients who have developed an intolerance to another BTK inhibitor necessitating permanent treatment withdrawal.

For patients with relapsed and/or refractory multiple myeloma (RRMM), the PBAC recommended PBS listing for elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone, Also for the treatment of RRMM, the committee recommended listing of a new 1800 mg subcutaneous flat dosing regimen of daratumumab (Darzalex) in addition to the current 16 mg/kg intravenous weight-based dosing regimen.

PBS listing was recommended for the combination of decitabine+cedazuridine (Inqovi) for the treatment of myelodysplastic syndromes (MDS, classified as intermediate-2 or high-risk according to the International Prognostic Scoring System) and for people with chronic myelomonocytic leukaemia (CMML).

Venetoclax (Venclexta) received a recommendation for PBS listing in combination with azacitidine, for the treatment of patients with newly diagnosed acute myeloid leukaemia, who are ineligible for standard intensive remission induction chemotherapy. The PBAC said it was satisfied that venetoclax with azacitidine provided, for some patients, a significant improvement in efficacy over low-intensity azacitidine or low-dose cytarabine.

Other PBAC recommendations included PBS listings for ravulizumab (Ultomiris) in the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adults, and zanubrutinib (Brukinsa) for Waldenstrom macroglobulinaaemia.

However the PBAC did not recommend applications for PBS listing of selinexor (Xpovio) in a triplet regimen (SBd, with bortezomib and dexamethasone) for both patients with RRMM, for pentarefractory multiple myeloma or for patients with relapsed/refractory diffuse large B-Cell lymphoma (DLBCL).

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