New dosing option for AZ’s Imfinzi approved in the EU and UK
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.
Read more: http://www.pmlive.com/pharma_news/new_dosing_option_for_azs_imfinzi_approved_in_the_eu_and_uk_1361371
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.
Read more: http://www.pmlive.com/pharma_news/new_dosing_option_for_azs_imfinzi_approved_in_the_eu_and_uk_1361371
