Tags : Non-Small Cell Lung Cancer

Regulatory

Genentech’ Gavreto (pralsetinib) Receives the US FDA’s Approval Metastatic RET

Shots: The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors Results: ORR (57%) and CR rate (5.7%) […]Read More

MedTech

The US FDA Approves Guardant360 CDx as the First Liquid

Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic […]Read More

Biosimilars

Innovent Receives the NMPA’s Approval for Byvasda (biosimilar, bevacizumab) to

Shots: The NMPA has approved Byvasda for the treatment of patients with NSCLC and metastatic colorectal cancer. The approval follows TYVYT (sintilimab injection) approval, indicated to treat patients with Hodgkin’s lymphoma, granted in Dec’2018 The launch of Byvasda will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection In Jan’2020, Innovent granted […]Read More

Biotech

AstraZeneca and Daiichi Sankyo Provide Updates of Enhertu (fam-trastuzumab deruxtecan-nxki)

Shots: The two companies divulged the results of ongoing P-II DESTINY-CRC01 study assessing Enhertu in patients with HER2+ unresectable and/or m-colorectal cancer, prior treated with 2L standard therapies. Results: ORR (45.3%); DCR (83.0%); PFS (6.9mos.); subgroup patients including patients with treated with a prior anti-HER2 regimen, ORR (43.8%) with a median treatment duration of 4.8mos. […]Read More

Biotech

Roche Reports Updated Data of Alecensa in P-III ALEX Study

Shots: The P-III ALEX study involves assessing of Alecensa vs crizotinib in 303 treatment-naïve patients in a ratio (1:1) with ALK+ NSCLC whose tumors were characterized as ALK+ by the VENTANA ALK (D5F3) CDx Assay Updated results: OS @5yrs. (62.5% vs 45.5%); reduction in the risk of death in patients with/ without CNS metastases (42%/ […]Read More