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New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

AstraZeneca’s (AZ) PD-L1 inhibitor Imfinzi (durvalumab) has been granted approval in the European Union and the UK for a new dosing option in locally advanced, unresectable non-small cell lung cancer (NSCLC).

The additional option extends dosing from every two weeks to every four weeks, enabling patients to reduce their medical visits – an important factor in the current COVID-19 pandemic.

The new dosing regimen is consistent with Imfinzi’s approved dosing in extensive-stage small cell lung cancer (ES-SCLC).

The European Commission (EC) approval is based on data from a number of clinical trials evaluating Imfinzi – including the PACIFIC phase 3 trial which supported the two-week, weight-based dosing of 10mg/kg approval in NSCLC and the CASPIAN phase 3 trial which used a four-week fixed-dose regimen in ES-SCLC.

“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 Dave Fredrickson, executive vice president, oncology business unit, AZ.

“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,” he added.

The approval comes on the heels of an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The CHMP recommendation also applies to the UK, AZ added in a statement.

The four-week fixed-dose schedule for Imfinzi in NSCLC was also recently approved by the US Food and Drug Administration (FDA). The FDA also approved the additional dosing option for patients with previously treated advanced bladder cancer.

In AZ’s recent third quarter results, the British drugmaker reported that its oncology franchise had grown by 24% to $8.15bn – with Imfinzi accounting for $1.48bn of that amount.

The new dosing schedule, which involves fewer trips to the hospital and a flexible treatment option, could help to grow the drug’s position in the highly competitive NSCLC market.

Merck & Co’s checkpoint inhibitor Keytruda (pembrolizumab) currently holds much of the NSCLC market, although the drug failed to show benefit in ES-SCLC when added to chemotherapy.

The disappointing results in ES-SCLC marred an otherwise dominant position in lung cancer for Merck’s drug, which has become a new standard of care for newly-diagnosed NSCLC patients.

Article by
Lucy Parsons

15th January 2021

From: Regulatory



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