publication date: Jul. 19, 2019

Drugs & Targets

Australian regulator conditionally OKs expanded uses for Keytruda

Pembrolizumab (Keytruda) has become the first medicine to have additional indications registered on the Australian Register of Therapeutic Goods via the provisional approval pathway.

Pembrolizumab’s indications now include the treatment of patients with metastatic colorectal carcinoma and other solid tumors with certain types of mutations.

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.

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