Crizotinib (Xalkori) is now available through the PBS for lung cancer patients with a c-ROS proto-oncogene 1 (ROS1) gene rearrangement.

From 1 January the drug is subsidised for patients with Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer.

Meanwhile, other new and amended PBS listings have been recommended for several oncology drugs by the Pharmaceutical Benefits Advisory Committee at its November meeting.

For patients with unresectable hepatocellular carcinoma the PBAC recommended that lenvatinib (Lenvima) be PBS listed based on cost effectiveness compared to sorafenib. The committee also noted that rates of palmar-plantar erythrodysaesthesia syndrome were lower with lenvatinib compared to sorafenib, with potential benefits on quality of life.

Other PBS listings recommended at the PBAC meeting include:

• Nivolumab in combination with ipilimumab (Opdivo and Yervoy) for the first-line treatment of Stage IV clear cell variant renal cell carcinoma (RCC) in patients at intermediate to poor prognostic risk.
• Osimertinib (Tagrisso ) for the treatment of EGFR T790M mutation positive NSCLC. The PBAC acknowledged that osimertinib provides, for some patients, a significant improvement in efficacy and a reduction in toxicity over platinum-based doublet chemotherapy.
• Change from a weight-based to fixed dose regimen for pembrolizumab (Keytruda) in unresectable stage III or Stage IV malignant melanoma.
• Listing of the Fulphila biosimilar brand of pegfilgrastim for chemotherapy-induced neutropenia as equivalent to the reference brand Neulasta.

In addition to its listing recommendations, the PBAC also advised the health minister and the federal health department to consider a broad PBS subsidy listing for PD-(L)1 inhibitors for non-small cell lung cancer (NSCLC.)

The committee said there was substantial evidence and experience available for four PD-(L)1 medicines (atezolizumab, durvalumab, nivolumab and pembrolizumab) in this setting.

“The PBAC considered there is potential for a NSCLC listing that allows patients of WHO performance status 0 and 1 access to a single course of treatment with a PD-(L)1 inhibitor, irrespective of disease stage (unresectable stage III or IV), biomarker status, line of treatment (adjuvant, 1st or later line), and with or without concomitant cytotoxic therapy,” its statement said.

“This would allow the decision regarding timing the PD-(L)1 inhibitor to be determined by the clinician and patient.”