AZ aims to cut cancer clinic visits with new Imfinzi regimen
The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients with lung and bladder cancer.
The regulator has granted a faster six-month Priority Review for the fixed dose regimen, based on data from several Imfinzi clinical trials, including results from the phase III CASPIAN trial in extensive stage small-cell lung cancer (ES-SCLC) which used the four-week, fixed-dose regimen during maintenance.
AZ hopes that the new dosing regimen will be able to offer patients and doctors an alternative to the existing fortnightly regimen, allowing the drug to gain traction and taking pressure off clinics during the COVID-19 pandemic.
The strategy is similar to one employed by Merck & Co, which has extended the length of the dosing regimen for its rival immunotherapy Keytruda from three to six weeks in certain indications.
The FDA grants Priority Review to applications for medicines that offer significant advances over available options for serious diseases in terms of safety, efficacy preventing serious conditions, or patient compliance.
Cutting the number of visits to clinics is an important factor in getting patients to comply with regimens, saving on travel costs and reducing the impact on patients’ lives.
A regulatory decision is due during the fourth quarter of 2020.
Dave Fredrickson, executive vice president at AstraZeneca’s oncology unit, said: “The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting.
“This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications.”
Imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the phase 3 PACIFIC trial.
Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.
It is also approved in the US and under review in Japan and other countries for ES-SCLC. Imfinzi was also recently recommended for marketing authorisation in the EU for this indication.
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