HER2-targeted bispecific antibody ZW25 will be used in combination with other drugs for HER2-positive breast cancer and gastroesophageal adenocarcinoma.
The approval limits the drug's use to patients who are refractory or intolerant to standard-of-care treatments and contains warnings about the risk of interstitial lung disease.
The FDA had previously approved neratinib as an extended adjuvant therapy for patients with early-stage HER2-overexpressed or amplified breast cancer, following adjuvant treatment with trastuzumab.
The NDA, based on data from a randomized Phase II trial, is for the use of tucatinib combined with trastuzumab and capecitabine for HER2-positive breast cancer patients.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
