Tags : Indication

Regulatory

AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in

Shots: The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements […]Read More

Pharma

Chipscreen Bioscience’s Epidaza (chidamide) Receives NMPA Approval for Breast Cancer

Shots: The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal patients with HR+, HER2- advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression Chidamide (CS055/HBI-8000/tucidinostat) is an orally available low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes targeting subtype […]Read More

MedTech Regulatory

Medtronic Resolute Drug-Eluting Stent (DES) Platform Receives FDA’s Approval for

Shots: The expanded indication approval is based on PERSPECTIVE Study assessing 183 patients with older-generation Resolute Integrity DES The study resulted in low rates of repeat revascularization 1.1%, cardiac death 2.2%, minimal stent thrombosis 0.06% and safe results Resolute Drug-Eluting Stent (DES) platform includes Resolute Onyx and Resolute Integrity DES targeted for the treatment of […]Read More

Biotech

Amgen’s Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph-

Shots: The expanded approval is based on P-II BLAST study results assessing Blincyto (15ug/m2/d @4wks.) in patients with 3L + MRD-positive ALL in complete hematologic remission, evaluating its efficacy, safety, and tolerability The study resulted in complete MRD response or no detectable MRD, relapse-free survival, eliminating detectable residual disease with safe and effective results in […]Read More