Datopotamab deruxtecan

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.

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.

Lung cancer is a leading cause of cancer death globally, with NSCLC being the most common type. LAURA is a Phase III trial testing Tagrisso, a third-generation EGFR-TKI, in Stage III EGFRm NSCLC patients. Tagrisso has shown efficacy in various stages of NSCLC and is part of AstraZeneca's comprehensive lung cancer portfolio. The company aims to redefine cancer care and eliminate it as a cause of death.

FDA receives BLA for Dato-DXd in EGFR+ advanced NSCLC; RP1 plus nivolumab shows activity in advanced melanoma post-PD-1 therapy; 177Lu-PSMA-I&T meets rPFS endpoint in PSMA+ mCRPC; refined platinum resistance definition and novel ADCs impact ovarian cancer treatment; CHMP recommends isatuximab plus VRd for transplant-ineligible myeloma; CHMP also supports repotrectinib, pembrolizumab plus chemo, nivolumab plus ipilimumab, and denosumab biosimilars.

A new BLA for Dato-DXd in EGFR-mutated NSCLC was submitted, replacing the earlier nonsquamous NSCLC application, based on phase 2 and 3 trial data. This decision followed FDA feedback and aims for accelerated approval.

Syros Pharmaceuticals' phase III study for tamibarotene in MDS missed primary endpoint; Amgen's stock steady despite analyst report; Adaptimmune reports positive results for lete-cel; Daiichi Sankyo and Astrazeneca submit new BLA for lung cancer treatment; Apollo Therapeutics signs $938 million deal with Sunshine Lake Pharma; study identifies quiescent cancer stem cells in glioblastoma relapse; Modifi Biosciences acquired by Merck for up to $1.3 billion.