Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer
Ken Takeshita, Global Head, R&D Daiichi Sankyo, said: “This positive CHMP opinion recognises the unmet need in the European Union for patients with HER2-low metastatic breast cancer. Currently, once patients with HR-positive disease progress on hormone therapy there are limited effective treatments, and few targeted options are available for patients with HR-negative disease. We look forward to the European Commission decision and aim to bring Enhertu to eligible patients as soon as possible.”
Share:
More News
Søren Bregenholt, CEO of Alligator Bioscience, commented: “The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward
Abbisko Therapeutics announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib, has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC). Irpagratinib is the first therapeutic agent to leverage
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are very pleased that the NDA application for the fourth indication of our core product, sac-TMT, has been accepted by the CDE of NMPA, which is another breakthrough for the breast cancer treatment field. This not only verifies the clinical value and
“The clearance of our IND for AVZO-1418 is a significant achievement for Avenzo as this is our second IND in 3 weeks to receive clearance and our first ADC program to advance into the clinic,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “We believe AVZO-1418
