DAIICHI SANKYO, INC.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

GLP-1 drugs like semaglutide and tirzepatide have expanded uses beyond diabetes and weight loss, potentially treating cardiovascular disease, kidney disease, anxiety, depression, and substance use disorder. CRISPR drugs Casgevy for sickle cell disease and β-thalassemia entered the market, though uptake is slow due to complex treatment processes. Protein-folding algorithms by Baker, Hassabis, and Jumper revolutionized biochemical research and pharmaceutical applications. ADCs received significant investment, with firms exploring new linker chemistries. Amylyx Pharmaceuticals pulled an ALS drug after trial failure, continuing research for other uses. Kelly Chibale called for recognizing African scientific potential. Virologists monitored H5N1, mpox, and Marburg outbreaks, with ongoing research and emergency measures. Radiopharmaceuticals saw increased investment and market growth. Evidence suggests vaccines like shingles and flu jabs may protect against dementia.

Datopotamab deruxtecan granted Breakthrough Therapy Designation in US for treating advanced EGFR-mutated NSCLC after EGFR-TKI and platinum-based chemotherapy. Based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trial data, presented at ESMO Asia 2024.

AstraZeneca and Daiichi Sankyo's cancer drug dato-dxd showed tumor control for 6 months in EGFR-mutated lung cancer patients; Agenus plans 60% spending cut to focus on late-stage colorectal cancer immunotherapy; Amgen invests $1 billion to expand NC manufacturing; USPTO withdraws proposed rule on preventing 'patent thickets'; Bluebird bio to undergo reverse stock split; FDA grants accelerated approval to Merus' zenocutuzumab for NRG1-altered lung and pancreatic cancers.

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.

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 grants Merck's sacituzumab tirumotecan (sac-TMT) breakthrough therapy designation for advanced non-squamous NSCLC with EGFR mutations, post-chemotherapy progression. This marks the first BTD for sac-TMT, an ADC developed with Kelun-Biotech, with Merck holding global marketing rights except in Greater China.

Maneesh R. Jain, MD, discusses a case of HER2-positive prostate cancer treated with trastuzumab deruxtecan-nxki (Enhertu), highlighting the patient's dramatic response and the importance of HER2 expression testing in prostate cancer. A clinical trial (CaRPET) is planned to explore this treatment further.