AstraZeneca’s Imfinzi gets EU and UK approval for new dosing option
AstraZeneca’s Imfinzi (durvalumab) has been approved in the EU and the UK for an additional dosing option in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells, and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
The new dosing option – a 1,500mg fixed dose every four weeks – is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC), and is available to patients with locally advanced, unresectable NSCLC weighing more than 30kg.
Approval by the European Commission was based on data from several Imfinzi clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing of 10mg/kg already approved in locally advanced, unresectable NSCLC, and the CASPIAN Phase III trial which used four-week, fixed dosing during maintenance treatment in ES-SCLC.
The authorisation follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, which recommended the drug’s approval in December. Europe’s recommendation and approval of Imfinzi also applies to the UK.
Lung cancer is the leading cause of cancer death and 80 to 85% of patients with lung cancer have NSCLC. Approximately one third of patients are diagnosed in the Stage III setting; the majority of these patients have unresectable tumours and are treated with curative intent.
Dr Luis Paz-Ares, Chair of the Medical Oncology Department at Hospital Universitario Doce de Octubre, in Spain and principal investigator in the CASPIAN Phase III trial, said: “Less-frequent dosing is important for cancer patients, and may be particularly relevant right now for those suffering from lung cancer, who are especially vulnerable to complications from COVID-19.
“Patients with cancer should be able to focus on living their lives as much as possible and doctors can now offer them a more convenient dosing option that could reduce medical visits by half and help avoid unnecessary risk of exposure to infection in the healthcare setting.”
Dave Fredrickson, Executive Vice President of the Oncology Business Unit, added: “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. 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.”
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