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AstraZeneca gets recommendation for new Imfinzi dosing option
15th Dec 2020 07:17
(Sharecast News) - AstraZeneca announced on Tuesday that 'Imfinzi', or durvalumab, had been recommended for marketing authorisation in the European Union for an additional dosing option.
The FTSE 100 pharmaceuticals giant said the new option was a 1,500mg fixed dose every four weeks, in the approved indication of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours expressed PD-L1 on at least 1% of tumour cells, and whose disease had not progressed following platinum-based chemoradiation therapy.
It said the new dosing option was consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and once approved, would be available to patients with locally-advanced, unresectable NSCLC weighing more than 30 kilograms.
Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the 'PACIFIC' phase 3 trial, which supported the two-week, weight-based dosing of 10mg per kilogram every two weeks already approved in locally advanced, unresectable NSCLC, and the 'CASPIAN' phase 3 trial, which used fixed dosing every four weeks during maintenance treatment in ES-SCLC.
"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," said executive vice-president of oncology research and development, José Baselga.
"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."
Imfinzi was recently approved in the United States for the new dosing regimen.
It was already approved in the curative-intent setting of unresectable, stage 3 locally-advanced NSCLC after chemoradiation therapy in the EU, US, Japan, China and a number of other countries, based on the 'PACIFIC' phase 3 trial.
Additionally, it was approved in the EU, US, Japan and other countries for the treatment of extensive-stage small-cell lung cancer based on the 'CASPIAN' phase 3 trial.
The FTSE 100 pharmaceuticals giant said the new option was a 1,500mg fixed dose every four weeks, in the approved indication of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours expressed PD-L1 on at least 1% of tumour cells, and whose disease had not progressed following platinum-based chemoradiation therapy.
It said the new dosing option was consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and once approved, would be available to patients with locally-advanced, unresectable NSCLC weighing more than 30 kilograms.
Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the 'PACIFIC' phase 3 trial, which supported the two-week, weight-based dosing of 10mg per kilogram every two weeks already approved in locally advanced, unresectable NSCLC, and the 'CASPIAN' phase 3 trial, which used fixed dosing every four weeks during maintenance treatment in ES-SCLC.
"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," said executive vice-president of oncology research and development, José Baselga.
"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."
Imfinzi was recently approved in the United States for the new dosing regimen.
It was already approved in the curative-intent setting of unresectable, stage 3 locally-advanced NSCLC after chemoradiation therapy in the EU, US, Japan, China and a number of other countries, based on the 'PACIFIC' phase 3 trial.
Additionally, it was approved in the EU, US, Japan and other countries for the treatment of extensive-stage small-cell lung cancer based on the 'CASPIAN' phase 3 trial.