About Orphan Drug and the “CASPIAN” –
The FDA has granted an orphan drug designation to “Durvalumab” (“Imfinzi”) for the treatment of patients with small cell lung cancer, SCLC.
Data supporting the orphan drug designation come from the phase III “CASPIAN” trial, which met its primary endpoint and announced in end of June 2019. In patients with extensive-stage SCLC, the addition of Durvalumab to standard chemotherapy demonstrated a statistically and clinically meaningful improvement in overall survival.
An orphan drug designation is granted to new therapies intended to treat rare diseases that affect less than 200,000 in the United States and allows for increased assistance from the FDA from the drug company for the final approval. SCLC accounts for about 15% of all lung cancer diagnoses and has a 5-year survival rate of approximately 6%.
About Imfinzi –
Durvalumab has received FDA approval for the treatment of patients with unresectable, stage III non–small cell lung cancer after chemoradiotherapy and for the treatment of previously treated patients with advanced bladder cancer.
The PD-L1 inhibitor is currently being investigated worldwide in patients with limited-stage SCLC in the phase III “ADRIATIC” trial.
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