Pembrolizumab (Keytruda) is the first medicine to have additional indications registered on the ARTG via the TGA’s provisional approval pathway
“Pembrolizumab’s indications now include the treatment of patients with metastatic colorectal carcinoma (bowel cancer) and other solid tumours with certain types of mutations (deficient mismatch repair),” the TGA says.
It advised that the medicine’s Product Information now provides more details on the types of cancers it can be used to treat.
“The provisional approval of pembrolizumab for treatment of patients with bowel cancer and other solid tumours was based on early clinical data in these specific types of mutations,” says the TGA.
“The continued approval of pembrolizumab for these new indications will depend on further evidence of clinical benefit from clinical trials being provided by the product sponsor.”
The TGA says that provisional approval allows it to approve some prescription medicines for a limited period of time while more research is conducted.
“We use the provisional approval pathway when a new medicine is a promising treatment for a serious or life-threatening condition but there is less research available on the medicine than we would normally require for the approval of a prescription medicine,” it says.