FDA has agreed to fast-track its regulatory review of Novartis’ capmatinib in a hard-to-treat form of lung cancer. Novartis said it has applied for capmatinib, developed in partnership with Incyte, to be marketed as a MET inhibitor for first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated
Roche’s Atezolizumab has won US clearance for use in combination with carboplatin and etoposide (chemotherapy) as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in the US, offering patients the first new treatment in more than 20 years. The approval follows data from the Phase III IMpower133 study, which showed that Atezolizumab in combination
AZ’s Tagrisso has been given a go-ahead in Europe for first-line use to treat EGFR-mutated non-small cell lung cancer (NSCLC), offering a new line of attack at this stage of the disease. The decision was based on clinical data from the Phase III FLAURA trial, showing that progression free survival in patients taking Tagrisso (osimertinib)
Three months after US regulators gave the treatment the green light, AstraZeneca’s new lung cancer pill, Tagrisso, has won early approval for use in the EU. Tagrisso, also known by its clinical name osimertinib AZD9291, is one of six cancer medicines that AstraZeneca hopes will rebuild its sales after losing patent on older drugs.