Company requests that new drug Apalutamide be put on the PBS for non-metastatic castrate-resistant prostate cancer: M0CRPC

[Admin]

Jim Marshall (not a doctor) said ...

A new drug has been developed and tested for men with castrate-resistant prostate cancer who have no metastases.

 

In the trial of Apalutamide (Erlyand®), half the men on the drug still had no sign of metastases at 40.5 months. In contrast, half the men on the placebo (dummy tablets) reached this point after 16.2 months.

 

The drug passed the first step in Australia by gaining  TGA (Therapeutic Goods Administration) approval in only 4 months. So, now it can be legally be prescribed and sold in Australia.

 

Today the company selling the drug (Janssen) took the next step by asking the Pharmaceutical Benefits Advisory Committee (PBAC) to approve the drug being put on the PBS so it is available to men who need it at an affordable price.

 

The listing is for the: "treatment of non-metastatic castration resistant prostate cancer in combination with androgen deprivation therapy".

 

The PBAC is seeking public submissions, and we will be trying to help this process.

 

One complication is that the evidence for the drug was gathered in the USA where the definition of non-metastatic is different from what people in Australia expect. In the coming weeks we expect to help our members understand this, and that quite a number of them may, perhaps to their surprise, meet the criteria for this drug.

... end Jim