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15 Jan 2021 | 08:06

AstraZeneca gets another approval for 'Imfinzi' in Europe

(Sharecast News) - AstraZeneca said on Friday that 'Imfinzi', or durvalumab, has been approved in the European Union and the UK for an additional dosing option - a 1,500mg fixed dose every four weeks - in locally advanced, unresectable non-small cell lung cancer (NSCLC). The FTSE 100 pharmaceuticals giant said the dosing option was for adults whose tumours expressed PD-L1 on at least 1% of tumour cells, and whose disease had not progressed following platinum-based chemoradiation therapy (CRT).

It said lung cancer was the leading cause of cancer death, with between 80% and 85% of patients with lung cancer having NSCLC.

About one third of patients were diagnosed in the stage 3 setting, with the majority of those having unresectable tumours, treated with curative intent.

The new dosing option was consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC), AstraZeneca said, and was available to patients with locally-advanced, unresectable NSCLC weighing more than 30 kilograms.

It said the approval by the European Commission was based on data from several Imfinzi clinical trials.

Those included the 'PACIFIC' phase 3 trial, which supported the two-week weight-based dosing of 10mg per kilogram, already approved in locally advanced, unresectable NSCLC, and the 'CASPIAN' phase 3 trial which used four-week, fixed dosing during maintenance treatment in ES-SCLC.

The approval followed an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which recommended approval in December 2020.

That CHMP recommendation and approval also applied to the UK.

"We are pleased to offer a four-week dosing option to lung cancer patients in Europe to meet an urgent need and help enable continuity of care during the pandemic," said executive vice-president of AstraZeneca's oncology business unit, Dave Fredrickson.

"Cancer won't wait, and it is our job to provide patients with treatment options that address the challenges the pandemic poses to their care."

Imfinzi was also recently approved for unresectable stage 3 NSCLC after CRT in the United States for the four-week, fixed-dose regimen.

It was already approved in the curative-intent setting of unresectable, stage 3 locally-advanced NSCLC after CRT in the EU, the 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 ES-SCLC based on the 'CASPIAN' phase 3 trial.

At 0810 GMT, shares in AstraZeneca were down 0.41% at 7,528p.
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