Tags : Breast Cancer

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic

Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]Read More

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019 The assay is designed to be completed within the same day, enabling clinicians to get […]Read More

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More

Zebra Medical Receives the US FDA’s Approval for its HealthMammo

Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result […]Read More

Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062

Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer respectively The research program includes two P-II studies evaluating the efficacy, safety, and markers of response and resistance to DS-1062 & patritumab deruxtecan in […]Read More

Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for

Shots: The MAA validation is based on P-II DESTINY-Breast01 trial assessing Trastuzumab Deruxtecan as a monothx in patients with 2L+ HER2 positive metastatic breast cancer and the results were published in the NEJM The EMA’s CHMP validation provides the application is complete and commences the scientific review process while CHMP’s accelerated assessment is granted to […]Read More

Zionexa And Petnet Solutions’ Cerianna (Fluoroestradiol F 18) Receive the

Shots: Cerianna (Fluoroestradiol F 18) is a novel FDA approved molecular imaging agent targeted for PET imaging for detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer The product will also allow the clinicians better guide treatments for metastatic breast cancer patients and improve patients’ QoL […]Read More

Seattle’s TUKYSA (tucatinib) Receives the US FDA’s Approval for Advanced

Shots: The approval is based on HER2CLIMB study assessing TUKYSA in combination with trastuzumab and capecitabine vs trastuzumab & capecitabine monothx in ratio (2:1) in 612 patients with 1L+ Anti-HER2 therapies in the metastatic setting either monothx or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1) The study resulted in 46% reduction in the risk […]Read More

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