Medicines

Two prostate cancer therapies in latest round of PBAC approvals for oncology


Two therapies for prostate cancer are among a range of oncology drugs recommended for PBS listing at the November meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).

Apalutamide (Erlyand) was recommended for the treatment of patients with non-metastatic castration resistant prostate cancer.

The PBAC said was satisfied that “apalutamide provides, for some patients, a moderate overall survival benefit compared to standard of care and was non-inferior in terms of efficacy and safety compared to darolutamide.”

It also recommended potential flow on changes to the PBS restrictions for darolutamide, abiraterone and enzalutamide to prevent the subsequent use of novel hormonal agents.

However the committee rejected an application from sponsor Janssen-Cilag for PBS listing of apalutamide for the treatment of metastatic hormone sensitive prostate cancer (mHSPC) in patients who have low volume disease, or high volume disease and who are unsuitable for chemotherapy.

At the same meeting, olaparib (Lynparza) received a positive approval for the treatment of metastatic castration resistant prostate cancer in patients with BRCA1 and BRCA2 pathogenic gene variants who have progressed following a prior novel hormonal agent.

The committee was satisfied that olaparib provides, for some patients, a significant improvement in efficacy over standard care(best supportive care and cabazitaxel)  based on the results of the PROfound study.

In other PBAC decisions, the committee made a positive recommendation for PBS listing of cemiplimab (Libtayo) for the treatment of previously untreated metastatic NSCLC, in patients with a programmed cell death ligand 1 (PD-L1) tumour proportion score (TPS) ≥50%.

It also recommended listing of a new biosimilar brand of bevacizumab, Abevmy, for the same conditions as the currently listed biosimilar brand, Mvasi. These indications include relapsed or recurrent glioblastoma; Advanced (unresectable) Barcelona Clinic Liver Cancer; Stage B or Stage C hepatocellular carcinoma; Stage IV (metastatic) non-small cell lung cancer (NSCLC); Advanced carcinoma of cervix; Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer; Metastatic colorectal cancer.

The PBAC deferred a decision on listing of tepotinib (Tepmetko) for the treatment of locally advanced or metastatic IV NSCLC patients who have evidence of a MET proto-oncogene, receptor tyrosine kinase (MET) gene alteration that causes skipping of exon 14 (METex14sk).

Four PBS listing applications for oncology drugs that were not recommended by the PBAC were::

  • Nivolumab (Opdivo) plus chemotherapy for the first-line treatment of patients with non-HER2-positive advanced or metastatic gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma.
  • Pembrolizumab (Keytruda) in combination with platinum-based chemotherapy, for the treatment of locally advanced (Stage III) or metastatic (Stage IV) oesophageal adenocarcinoma or oesophageal squamous cell carcinoma, or HER2-negative adenocarcinoma of the gastro-oesophageal junction.
  • Regorafenib (Stivarga) for the treatment of metastatic colorectal cancer (mCRC) after treatment with two or more prior therapies
  • Sacituzumab govitecan (Trodelvy) for the treatment of unresectable, locally advanced or metastatic triple negative breast cancer (TNBC).

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