The Food and Drug Administration (FDA) has granted Orphan Drug designation to Imfinzi (durvalumab; AstraZeneca) for the treatment of small cell lung cancer (SCLC).

The multicenter, open label, global, phase 3 CASPIAN trial evaluated the efficacy and safety of Imfinzi for patients with extensive-stage SCLC. Patients were randomized to receive Imfinzi in combination with standard of care etoposide and platinum-based chemotherapy compared with chemotherapy alone. Results showed a statistically significant improvement in overall survival (primary end point) for patients treated with Imfinzi. Full study findings will be shared at a forthcoming medical meeting.

“This Orphan Drug designation comes on the heels of positive results from the Phase 3 CASPIAN trial, which is the first trial to offer the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer,” said José Baselga, Executive Vice President, R&D Oncology. “We are eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible.”

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Currently, Imfinzi, a programmed death-ligand 1 (PD-L1) blocking antibody, is indicated for treatment of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after concurrent platinum-based chemotherapy and radiation. In addition, the treatment is approved for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

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