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First provisional approval

17 July 2019

Pembrolizumab (KEYTRUDA) has become the first medicine to have additional indications registered on the Australian Register of Therapeutic Goods (ARTG) via our 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 Product Information provides more detail on the types of cancers that can now be treated with pembrolizumab.

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. 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.

Further information on provisional approval is available on the TGA website for: