The FDA hasapprovedAmgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for the treatment ofHER2-positive breast cancer and gastric cancer. The news of the approval comes just a week after the 2019 American...
FDA approval was granted based on a comprehensive package of analytical, preclinical, and clinical data, which showed trastuzumab-strf and its reference product, trastuzumab are highly similar in terms of efficacy, safety, and quality. The clinical program for trastuzumab-strf included three studies ...
On October 20, 2010, FDA approved trastuzumab (Herceptin, Genentech) for use in combination with cisplatin and capecitabine or 5-fluorouracil to treat patients with human epidermal growth factor receptor 2-overexpressing metastatic gastric or gastroesophageal junction cancer who have not...
Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer 2024-09-21 13:42 4517Henlius Trastuzumab Receives FDA Approval in the United States 2024-04-29 20:18 2789 Henlius Releases 2023 ESG Report: Pursuing Sustainable Development wit...
A fourth trastuzumab biosimilar has been granted approval by the FDA. The approval was for PF-05280014 for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma....
FDA Approved Drug Products: Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) for subcutaneous injection [Link] Health Canada Product Monograph: ONTRUZANT (trastuzumab) intravenous infusion [Link] GlobeNewsWire: Samsung Bioepis Announces Health Canada Approval of 150mg Single-use Vial and 440mg Multi...
Genentech, the manufacturer of trastuzumab, holds an exclusive license for the metastatic gastric cancer indication. The companies cannot market the drug for that purpose until the exclusive license expires. “The FDA continues to grow the number of biosimilar approvals, helping to promote competition...
Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and d...
Trastuzumab was granted FDA approval in 2010 for use in first-line treatment of HER2-positive advanced or metastatic gastric/GEJ adenocarcinoma in combination with systemic chemotherapy with either capecitabine or 5-fluorouracil (5-FU) plus cisplatin based on the landmark international, open-label phas...
The FDA has granted an Orphan Drug designation to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with gastric or gastroesophageal junction (GEJ) cancer.1 This decision was based on findings from the phase II DESTINY-Gastric01 clinical trial, in which the HE...