Cabozantinib (Cabometyx) will be available on the PBS from 1 July 2021 as a first line treatment for stage IV clear cell variant renal cell carcinoma (RCC).

The once daily oral tyrosine kinase inhibitor has been available as a second line treatment for patients with advanced RCC since 2018.

At its November 2020 meeting, the PBAC said it was satisfied that cabozantinib provides, for some patients, an improvement in PFS versus sunitinib, however an improvement in OS was not supported by the evidence presented.

“As cabozantinib is expected to be used for a longer duration due to increased PFS, the PBAC noted that cabozantinib would result in a higher total estimated drug cost per patient than sunitinib and considered that this was appropriate because it would be offset by lower post-progression costs,” the PBAC Public Summary Document said.

The evidence in the treatment-naïve setting was based on the CABOSUN trial, a relatively small (n=157) Phase II open-label trial of cabozantinib versus sunitinib.

Median PFS was 8.2 months (95% CI, 6.2 to 8.8 months) with cabozantinib versus 5.6 months (95% CI, 3.4 to 8.1 months) with sunitinib.

“Cabozantinib reduced the rate of disease progression or death by 34% compared with sunitinib (adjusted HR for progression or death, 0.66, 95%, CI 0.46 to 0.95; one-sided P = .012),” the study said.

Health Minister Greg Hunt said in a statement that more than 800 Australians with stage IV advanced or metastatic renal cancer will now have access to subsidised cabozantinib treatment.