Posted by Michael Wonder on 04 Jun 2020
New small cell lung cancer drug accepted for TGA evaluation under Project Orbis
3 June 2020 - TGA has granted provisional designation for new drug lurbinectedin based on encouraging Phase 2 results and high unmet medical need.
A novel marine-derived drug to treat small cell lung cancer has been granted a provisional designation by the TGA, based on encouraging results from an international trial evaluating its safety and efficacy in several solid tumours, including small cell lung cancer.
Data from a key Phase 2 study of the drug lurbinectedin demonstrated a 35% overall response rate in second-line patients, with a median overall survival of 9.3 months (95% CI 6.3-11.8), which is a clinically meaningful advantage over current standard of care in patients in second-line therapy.
