18 de setembro de 2019

TGA NEWS: Provisional application receives approval through the first international collaborative review initiative between TGA, FDA and HC

From: www.tga.gov.au

TGA has provisionally approved the use of lenvatinib (Lenvima®) in combination with pembrolizumab (Keytruda®) for the treatment of certain patients with advanced endometrial carcinoma.

This provisional approval provides a treatment option for patients with advanced endometrial carcinoma (that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 

This indication was approved via the new provisional approval pathway (preliminary clinical data where there is the potential for a substantial benefit to patients), based on objective response rate and response duration in a single-arm trial. 

Full registration for this indication depends on verification and description of clinical benefit in the confirmatory clinical trials.

This evaluation has been facilitated through the Project Orbis initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) in which the FDA, Health Canada (HC), and the TGA received and collaboratively reviewed the application allowing for the simultaneous approval in all three countries. 

This innovative evaluation process has introduced efficiencies and established frameworks for process alignment and management of evaluation issues in real-time across jurisdictions.

Anyway, each regulatory agency has maintained its regulatory process to make an independent decision regarding approval (market authorization) of the new indication.