CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in th...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news
CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in th...
Source: Roche Investor Update - November 13, 2020 Category: Pharmaceuticals Source Type: news
Enhertu (fam-trastuzumab deruxtecan-nxki)
Title: Enhertu (fam-trastuzumab deruxtecan-nxki)Category: MedicationsCreated: 11/9/2020 12:00:00 AMLast Editorial Review: 11/9/2020 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - November 9, 2020 Category: Cancer & Oncology Source Type: news
Kadcyla (ado-trastuzumab emtansine)
Title: Kadcyla (ado-trastuzumab emtansine)Category: MedicationsCreated: 10/14/2020 12:00:00 AMLast Editorial Review: 10/14/2020 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - October 14, 2020 Category: Cancer & Oncology Source Type: news
HER2+ breast cancer patients live longer if drugs given before surgery eradicate tumour
(European Organisation for Research and Treatment of Cancer) Final analysis of results from a randomised clinical trial of lapatinib and trastuzumab given before surgery in patients with early HER2-positive breast cancer has found that women who had no signs of residual disease after treatment survived longer without the cancer returning than patients who did not. This was more likely to happen in patients who received the two anti-cancer drugs together, rather than as single agents. The research is presented at the 12th European Breast Cancer Conference. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 1, 2020 Category: Cancer & Oncology Source Type: news
Opening an autophagy window as the apoptosis door starts to close
(Tokyo Medical and Dental University) Tokyo Medical and Dental University (TMDU) researchers have successfully attached the cancer cell-targeting antibody Trastuzumab to a previously reported supermolecule that induces autophagic cell death. The antibody-drug conjugate (ADC) selectively targeted HER2-overexpressing cancer calls and reduced cell viability at lower concentrations than free supermolecule drug. It is hoped that the ADC will provide a targeted autophagic death route for treating apoptosis resistant cancer cells in vivo, and ultimately provide an alternate approach in the clinic. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - September 24, 2020 Category: Biology Source Type: news
Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to results ...
Source: Roche Media News - September 17, 2020 Category: Pharmaceuticals Source Type: news
Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to results ...
Source: Roche Investor Update - September 17, 2020 Category: Pharmaceuticals Source Type: news
Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 16, 2020 Category: Drugs & Pharmacology Source Type: news
Enhertu (Fam-trastuzumab Deruxtecan-nxki for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 8, 2020 Category: Drugs & Pharmacology Source Type: news
Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of O...
Source: Roche Investor Update - August 6, 2020 Category: Pharmaceuticals Source Type: news
Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of O...
Source: Roche Media News - August 6, 2020 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabl...
Source: Roche Investor Update - July 29, 2020 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabl...
Source: Roche Media News - July 29, 2020 Category: Pharmaceuticals Source Type: news
Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid ca...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news
