Lorbrena is approved as a second-line treatment for ALK-positive NSCLC but Pfizer believes data from the first-line Phase III CROWN study makes the drug a serious competitor to standard of care Alecensa in the first-line setting.

A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.

FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.