US biopharmaceutical company Amgen (NASDAQ:AMGN) announced on Monday that it has received marketing authorisation from the European Commission for IMDYLLTRA (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
This approval was based on results from DeLLphi-304, the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in this setting.
In the trial, IMDYLLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy.
Accord BioPharma's second pegfilgrastim biosimilar to NEULASTA approved by US FDA
BiBBInstruments signs first European distribution deal for EndoDrill GI with Palex Spain
IceCure reports growing adoption of ProSense cryoablation in Brazil
Aurinia initiates PRESERVE Phase 4 study of LUPKYNIS combination therapy in lupus nephritis
Genentech reports positive Phase III results for divarasib in KRAS G12C lung cancer
Neurocrine Biosciences initiates crinecerfont Phase 2 study in young children with classic CAH