Trastuzumab Deruxtecan

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Retrieved on: 
Tuesday, December 28, 2021
Health, Science, Pharmaceutical, Research, Oncology, HER2 Positive Breast Cancer, DESTINY-Breast03, Trastuzumab Deruxtecan, the Trastuzumab Deruxtecan Clinical Development Program, Daiichi Sankyo in Oncology, Daiichi Sankyo, HER2 POSITIVE BREAST CANCER, DESTINY-BREAST03, TRASTUZUMAB DERUXTECAN, THE TRASTUZUMAB DERUXTECAN CLINICAL DEVELOPMENT PROGRAM, DAIICHI SANKYO IN ONCOLOGY, DAIICHI SANKYO

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2 positive metastatic breast cancer.
  • Nearly all patients treated with trastuzumab deruxtecan were alive at one year (94.1%; 95% CI: 90.3-96.4) compared to 85.9% of patients treated with T-DM1 (95% CI: 80.9-89.7).
  • A Type II Variation is currently under review by the EMA for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen.

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for the Treatment of HER2 Positive Advanced Gastric Cancer

Retrieved on: 
Wednesday, November 3, 2021
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, HER2 Positive Gastric Cancer, DESTINY-Gastric01, DESTINY-Gastric02, Trastuzumab Deruxtecan, the Trastuzumab Deruxtecan Clinical Development Program, the Daiichi Sankyo and AstraZeneca Collaboration, Daiichi Sankyo in Oncology, Daiichi Sankyo, HER2 POSITIVE GASTRIC CANCER, DESTINY-GASTRIC01, DESTINY-GASTRIC02, TRASTUZUMAB DERUXTECAN, THE TRASTUZUMAB DERUXTECAN CLINICAL DEVELOPMENT PROGRAM, THE DAIICHI SANKYO AND ASTRAZENECA COLLABORATION, DAIICHI SANKYO IN ONCOLOGY, DAIICHI SANKYO

Patients were randomized 2:1 to receive trastuzumab deruxtecan or physicians choice of chemotherapy (paclitaxel or irinotecan monotherapy).

Key Points: 
  • Patients were randomized 2:1 to receive trastuzumab deruxtecan or physicians choice of chemotherapy (paclitaxel or irinotecan monotherapy).
  • Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC.
  • Trastuzumab deruxtecan consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.
  • A comprehensive global development program is underway evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers.

Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer

Retrieved on: 
Friday, December 11, 2020
Research, Infectious diseases, Clinical trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Clinical medicine, Medicine, Health, Cancer treatments, Breakthrough therapy, Immunology, Daiichi Sankyo, Trastuzumab deruxtecan, Antineoplastic drugs, HER2/neu, Trastuzumab, Breast cancer, HER2 Positive Breast Cancer, DESTINY-Breast01, Trastuzumab Deruxtecan, Daiichi Sankyo Cancer Enterprise, Daiichi Sankyo

Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe.

Key Points: 
  • Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe.
  • If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2 positive metastatic breast cancer.
  • HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3
    There remain significant unmet clinical needs for patients with HER2 positive metastatic breast cancer.
  • In July 2020, the EMAs CHMP granted trastuzumab deruxtecan accelerated assessment for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer

Retrieved on: 
Monday, July 6, 2020
FDA, Other Health, Health, Pharmaceutical, Oncology, Medicine, Clinical medicine, Cancer treatments, Genentech, RTT, Antineoplastic drugs, Immunology, Trastuzumab, HER2/neu, Breast cancer, Metastatic breast cancer, Trastuzumab emtansine, HER2, HER2 Positive Breast Cancer, Trastuzumab Deruxtecan, Daiichi Sankyo

Trastuzumab deruxtecan was granted accelerated assessment by the EMAs Committee for Medicinal Products for Human Use (CHMP).

Key Points: 
  • Trastuzumab deruxtecan was granted accelerated assessment by the EMAs Committee for Medicinal Products for Human Use (CHMP).
  • The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing, said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo.
  • The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens.
  • Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.

Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2 Positive Metastatic Gastric Cancer

Retrieved on: 
Thursday, May 7, 2020
Pharmaceutical, Health, Oncology, Clinical trials, Medicine, Clinical medicine, Cancer treatments, Genentech, Immunology, Antineoplastic drugs, HER2/neu, Trastuzumab, Trastuzumab emtansine, Tucatinib, HER2, Gastric Cancer, DESTINY-Gastric01, Trastuzumab Deruxtecan, the Trastuzumab Deruxtecan Clinical Development Program, the Collaboration between Daiichi Sankyo and AstraZeneca, Daiichi Sankyo Cancer Enterprise, Daiichi Sankyo

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (sNDA) to Japans Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer.

Key Points: 
  • Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (sNDA) to Japans Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer.
  • Currently, there are no HER2 directed treatment options approved for patients with HER2 positive metastatic gastric cancer who have progressed after trastuzumab.
  • If approved, trastuzumab deruxtecan has the potential to meaningfully advance the treatment of patients with HER2 positive metastatic gastric cancer as the first ever antibody drug conjugate approved to treat this type of cancer.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2- positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.