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TGA Australia approves Zepzelca to treat patients with small cell lung cancer.- Specialised Therapeutics.
Zepzelca (lurbinectedin) has been approved by the Therapeutic Goods Administration (TGA) "for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy". Zepzelca is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.
The TGA approval of Zepzelca has been granted under a provisional regulatory pathway. The FDA and Australia's Therapeutic Goods Administration (TGA) collaborated via 'Project Orbis' to accelerate availability to Australian patients.
Condition: Small Cell Lung Cancer
Type: drug