FDA immunotherapy first with the approval of AZ’s Imfinzi in first-line extensive-stage small cell lung cancer
pharmafile | March 30, 2020 | News story | Sales and Marketing | AstraZeneca, Cancer, FDA, Imfinzi, lung cancer, pharma
AstraZeneca has seized FDA approval for its immune checkpoint inhibitor Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
The approval relates to Imfinzi when used in combination with standard-of-care chemotherapies etoposide plus either carboplatin or cisplatin (platinum-etoposide).
Phase 3 data supporting the application showed that a fixed dose of Imfinzi 1500mg, in combination with chemo, administered every three weeks for four treatment cycles and then every four weeks until disease progression, led to “statistically significant and clinically meaningful improvement in overall survival (OS)” in patients compared to chemo alone.
The data showed that the Imfinzi reduced risk of death by 27% and recorded a median OS of 13 months compared to 10.3 months with chemo alone. The combo also generated a 68% objective response rate in patients, compared to 58% with chemotherapy.
“The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options,” commented Dave Fredrickson, Executive Vice President at AZ’s Oncology Business Unit. “Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”
The drug recently secured approval in Singapore for the same indication back in February this year and is currently undergoing review in Japan.
Matt Fellows
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