EMA panel recommends label extension of AstraZeneca’s Imfinzi in non-small cell lung cancer
pharmafile | December 15, 2020 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, Europe, Imfinzi, NSCLC
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed a new dosing regimen of AstraZeneca’s Imfinzi (durvalumab) in the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC), recommending the drug be made available in the European Union in a 1,500mg fixed dose every four weeks rather than every two weeks.
The label extension only applies to NSCLC patients in whom more than 1% of their tumour cells express PD-L1 and who have seen their disease halted through platinum-based chemoradiation therapy (CRT).
The decision was built on previous Phase 3 data supporting the previous approval of Imfinzi when administered in a 10mg/kg dose every two weeks, and incorporated positive Phase 3 findings supporting the drug’s use every four weeks for the maintenance of extensive-stage NSCLC.
“The four-week dosing regimen will decrease the risk of exposure to infection in the healthcare setting, furthering our efforts to ensure continuity of care for cancer patients at high risk of complications during the pandemic,” remarked AstraZeneca’s José Baselga, Executive Vice President, Oncology R&D. “We look forward to offering non-small cell lung cancer patients in Europe an option that would reduce medical visits by extending dosing from two to four weeks.”
The decision follows recent approval of Imfinzi from the FDA in November in the same indication.
Matt Fellows
Related Content
AstraZeneca shares results for Imfinzi in phase 3 trial for small cell lung cancer
AstraZeneca has announced positive high-level results from the phase 3 ADRIATIC trial, which demonstrated that …
FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment
AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan …
FDA approves AstraZeneca’s Ultomiris for NMOSD treatment
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) …
