Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Tuesday that they have voluntarily withdrawn their marketing authorisation application (MAA) for datopotamab deruxtecan in the European Union for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
This decision follows feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Daiichi Sankyo and AstraZeneca will continue to investigate the potential of datopotamab deruxtecan in other lung cancer settings through an ongoing clinical development programme.
Datopotamab deruxtecan is an antibody-drug conjugate (ADC) being jointly developed by the two companies.
The EU application for datopotamab deruxtecan in hormone receptor-positive, HER2-negative metastatic breast cancer remains under review.
The TROPION-Lung01 trial, a global phase 3 study, evaluated the efficacy and safety of datopotamab deruxtecan compared to docetaxel in patients with NSCLC.
ImmunityBio partners with BeiGene for Phase 3 NSCLC trial of ANKTIVA and PD-1 inhibitor
ANGLE plc reports successful dual CTC-DNA and ctDNA analysis using Illumina platform
Median Technologies secures funding for eyonis Lung Cancer Screening software
Genprex commences Phase 2 expansion of Acclaim-3 clinical study in ES-SCLC
Vast Therapeutics receives USD2m grant from National Institutes of Health
Nanobiotix reports first patient dosed in Phase 2 lung cancer study
AstraZeneca's Datroway approved in US for HR-positive breast cancer
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
RYBREVANT approved in Canada for second-line EGFR-mutated lung cancer
OS Therapies reports positive Phase 2b data for OST-HER2 in lung metastatic osteosarcoma
Creo Medical Group plc launches robotic-guided lung ablation procedures in the UK
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
HUTCHMED receives full NMPA approval for ORPATHYS in China for MET exon 14 skipping NSCLC
bioAffinity Technologies declares successful beta launch of CyPath Lung in Texas