Datopotamab deruxtecan

AstraZeneca's Imfinzi approved in the US for limited-stage small cell lung cancer (LS-SCLC) after chemotherapy and radiation, based on ADRIATIC trial results showing improved survival and reduced risk of death and disease progression.

FDA grants Priority Review to AstraZeneca's Imfinzi for muscle-invasive bladder cancer, based on NIAGARA Phase 3 trial data showing a 32% reduction in disease progression risk. Estimated 67.8% event-free survival at two years with Imfinzi versus 59.8% in the comparator arm. Imfinzi also reduced death risk by 25% in overall survival analysis.

Imfinzi (durvalumab) is a PD-L1 inhibitor used in various cancer treatments, including NSCLC, SCLC, biliary tract cancer, and endometrial cancer. AstraZeneca, a global biopharmaceutical company, focuses on oncology, rare diseases, and bio-pharmaceuticals, aiming to redefine cancer care and eliminate it as a cause of death.

AstraZeneca's Imfinzi (durvalumab) approved in the US for limited-stage small cell lung cancer (LS-SCLC) treatment, showing a 27% reduction in death risk versus placebo. ADRIATIC Phase III trial results demonstrated significant survival benefits, marking a breakthrough in LS-SCLC therapy.

Imfinzi (durvalumab) is a PD-L1 inhibitor used in various cancer treatments, including NSCLC, SCLC, biliary tract cancer, and endometrial cancer. AstraZeneca is a leader in oncology, focusing on early detection and innovative treatments for lung cancer and immuno-oncology, aiming to redefine cancer care and eliminate it as a cause of death.

FDA decisions in December include BeiGene's Tevimbra for gastric cancer, Ionis Pharma's Olezarsen for familial chylomicronemia syndrome, Lexicon Pharma's Zynquista for type 1 diabetes, AstraZeneca's Datopotamab deruxtecan for lung cancer, Zealand Pharma's Glepaglutide for short bowel syndrome, Rhythm Pharma's IMCIVREE for obesity in children, Soleno's DCCR for Prader-Willi syndrome, Checkpoint's Cosibelimab for skin cancer, Mirum's Chenodiol for cerebrotendinous xanthomatosis, Bristol-Myers' subcutaneous Opdivo, and Neurocrine's Crinecerfont for congenital adrenal hyperplasia.

Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) receives NMPA approval in China for triple-negative breast cancer, competing with Gilead's Trodelvy. The drug, also under review for EGFR-mutant NSCLC, is partnered with MSD, potentially worth up to $1.4 billion. Phase 3 study results showed a 47% reduction in death risk.

Revumenib approved for R/R KMT2A-rearranged acute leukemia; datopotamab deruxtecan seeks accelerated approval for EGFR-mutated NSCLC; managing CML requires open communication; CLL patients progressing despite BTK inhibitors and venetoclax; quadruplet regimen shows improved response in transplant-eligible multiple myeloma.

AstraZeneca and Daiichi Sankyo submitted a Biologics License Application for accelerated US approval of datopotamab deruxtecan to treat EGFR-mutated NSCLC in adults post-systemic therapies. Supported by TROPION-Lung05 Phase II, TROPION-Lung01 Phase III, and TROPION-PanTumor01 Phase I trials, it shows promise for EGFR-mutated patients. Datopotamab deruxtecan, a TROP2-directed DXd antibody drug conjugate, offers hope against resistant EGFR-mutated NSCLC.