Inotuzumab (Besponsa) will be available on the PBS from 1 May for patients with acute lymphocytic leukaemia (ALL).

The new PBS listing for the an anti-CD22 antibody Therapy, announced as part of the 2019 Federal Budget, will be for the treatment of relapsed or refractory CD22 positive B-cell precursor ALL.

The listing will mean that patients will get subsidised access to a treatment that would otherwise cost $120,000 a course.

At its November meeting the PBAC concluded that sequential use of inotuzumab and blinatumomab (in either order) “would be clinically appropriate in some patients given the differing mechanisms of action and the clinical role for additional therapeutic options for patients who are unable to receive a haematopoietic stem cell transplant (HSCT) or who progress after a HSCT.”

A 2016 study in the NEJM noted that current standard chemotherapy regimens for adults with relapsed or refractory B-cell ALL were associated with rates of complete remission of 31 to 44% when they are the first salvage therapy administered after an early relapse and 18 to 25% when they are the second salvage therapy.

The study of 326 patients with relapsed or refractory acute lymphoblastic leukemia found that progression-free survival was significantly longer in the inotuzumab ozogamicin group (median, 5.0 months  vs. 1.8 months) and the median overall survival was 7.7 months versus 6.7 months.