notably its blockbuster antibody cancer drug Herceptin (trastuzumab), by combining it with an enzyme that opens up channels in the extracellular matrix. San Diego–based Halozyme Therapeutics is ...

received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by ...

While the pembrolizumab copy was eye-catching, the firm’s next big biosimilar launch in Europe is a version of Roche’s Herceptin (trastuzumab). Biosimilar companies are poised to launch ...

Number of Medicare claims for trastuzumab originator (Herceptin) and 5 biosimilars, by month, 2019–20 Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases ...

Therapies that specifically target HER2 include Herceptin (trastuzumab), Perjeta (pertuzumab), and T-DM1 (trastuzumab emtansine) which is sold under the brand name Kadcycla. Treatment of early ...

Ontruzant, the first biosimilar version of Roche’s Herceptin (trastuzumab) in Europe has been launched in the UK by MSD. Developed by Korean biosimilar specialists Samsung Bioepsis, MSD is the ...

Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).

Patients could receive trastuzumab to complete therapy if T-DM1 was discontinued early. 2 Statistical methods and assumptions for the primary analysis have been described in detail 2; the same ...

Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...

The development, pharmacology, safety, efficacy, and dosage and administration of trastuzumab are reviewed. The discovery of HER2 gene amplification in up to 30% of women with breast cancer led to ...

Ogivri was the first biosimilar trastuzumab approved by the United States Food and Drug Administration (USFDA), the statement said. It is approved for all indications of Herceptin including for ...