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 ...

Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s ...

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

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 ...

In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...

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).

Mundipharma has signed a deal with Celltrion to market a biosimilar of Roche’s Herceptin (trastuzumab ... It is approved in the same uses as the originator drug – for HER2-positive early ...

Called Phesgo, the new product contains the active substances in Herceptin (trastuzumab ... which declined 31% to CHF 3.1 billion in the same period as biosimilars ate into its market share.

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 ...

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 ...