Regulatory Focus™ > News Articles > 2019 > 7 > Merck’s Keytruda is First to Add Indications Under TGA’s Provisional Approval Pathway

Merck’s Keytruda is First to Add Indications Under TGA’s Provisional Approval Pathway

Posted 17 July 2019 | By Zachary Brennan 

Merck’s Keytruda is First to Add Indications Under TGA’s Provisional Approval Pathway

Australia’s Therapeutic Goods Administration (TGA) on Wednesday announced that Merck’s Keytruda (pembrolizumab) is the first medicine to have additional indications registered on the Australian Register of Therapeutic Goods (ARTG) via TGA’s provisional approval pathway.

Early clinical data allowed for the provisional approval to help treat patients with metastatic colorectal carcinoma, also known as bowel cancer, and other solid tumors with certain types of mutations (deficient mismatch repair). 

TGA’s provisional approval pathway limits such approvals to a maximum of six years on the market unless sponsors meet certain conditions or apply for full registration with sufficient clinical data to confirm the safety and efficacy of the medicine.

Eligibility criteria for the using the pathway include that the medicine treats a serious condition, that there’s a major therapeutic advance and that there’s evidence of a plan to submit comprehensive clinical data.

Keytruda similarly won accelerated approval from the US Food and Drug Administration (FDA) in May 2017 to treat adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high or mismatch repair deficient. 

In addition to Keytruda, TGA also granted its first provisional approval determination to Eli Lilly’s soft tissue sarcoma drug Lartruvo (olaratumab) in 2018. But a recently completed Phase 3 trial showed that Latruvo did not confirm the expected clinical benefit and Lilly said it would pull the treatment.

TGA first provisional approval

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