European Commission approves Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

             Basel, 19 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Kadcyla ® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.“Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This approval of Kadcyla will allow many more women with HER2-positive ea rly breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing. " The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes. Adjuvant treatment aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.1 People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.2 The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive dise...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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Authors: Montemurro F, Nuzzolese I, Ponzone R Abstract Introduction: The administration of chemotherapy before (neoadjuvant), rather than after surgery (adjuvant) in early breast cancer has been considered an optional strategy for patients with operable breast cancer. We reviewed this concept considering recent results in the field.Areas covered: Herein, the authors cover neoadjuvant chemotherapy with or without biologics in triple-negative and HER2-positive operable breast cancer with a focus on rates of complete pathological remission (pCR) in the breast and axilla. The impact of the CREATE X and KATERINE randomi...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
Authors: Nakazawa Y, Nakazawa S, Kurozumi S, Ogino M, Koibuchi Y, Odawara H, Oyama T, Horiguchi J, Fujii T, Shirabe K Abstract Biomarkers that can accurately predict treatment response are required for indicating optimal neoadjuvant treatments. The current study assessed the predictive value of secreted protein acidic and rich in cysteine (SPARC) mRNA expression for the response to neoadjuvant nab-paclitaxel (nab-PTX) therapy in patients with breast cancer. It was hypothesized that SPARC expression can affect the response to albumin-bound taxanes, including nab-PTX since SPARC binds albumin with a high affinity. Pr...
Source: Oncology Letters - Category: Cancer & Oncology Tags: Oncol Lett Source Type: research
Authors: Gunawan I, Hatta M, Benyamin AF, Islam AA Abstract OBJECTIVE: Hypoxia-associated biomarkers profiling may provide information for prognosis, staging, and subsequent therapy. We aim to evaluate whether the quantitative gene and protein expression of hypoxic response tumor markers - carbonic anhydrase IX (CAIX) and hypoxia- inducible factor 1 alpha (HIF1A) - may have a role in predicting survival in advanced breast cancer of Indonesian population. METHODS: Tumor tissues and peripheral blood samples were collected from treatment - naïve locally advanced (LABC) or metastatic breast cancer patients (MB...
Source: Asian Pacific Journal of Cancer Prevention - Category: Cancer & Oncology Tags: Asian Pac J Cancer Prev Source Type: research
This article summarizes the FDA review and the data supporting the approval of ado-trastuzumab emtansine as a component of treatment for patients with HER2-positive EBC with residual disease. PMID: 32217612 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer that does not respond to endocrine therapy or human epidermal growth factor receptor 2 (HER2)–targeted therapies. Individuals with TNBC experience higher rates of relapse and shorter overall survival compared to patients with receptor-positive breast cancer subtypes. Preclinical discoveries are needed to identify, develop, and advance new drug targets to improve outcomes for patients with TNBC. Here, we report that MYCN, an oncogene typically overexpressed in tumors of the nervous system or with neuroendocrine features, is heterogeneously exp...
Source: Science Translational Medicine - Category: Biomedical Science Authors: Tags: Research Articles Source Type: research
Conclusion: Tau protein expression can predict pCR before NACT in TNBC, but there was no correlation between Tau expression and DFS or OS. PMID: 32140269 [PubMed]
Source: Journal of Breast Cancer - Category: Cancer & Oncology Tags: J Breast Cancer Source Type: research
ConclusionsAddition of carboplatin to neoadjuvant chemotherapy significantly improved DFS and OS in patients with TNBC but not in those with hormone receptor-positive, HER2-negative breast cancer.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
Condition:   Early Breast Cancer Interventions:   Drug: Doxorubicin;   Drug: Cyclophosphamide;   Drug: Taxane;   Drug: Letrozole;   Drug: Abemaciclib;   Drug: LHRH Analogue Sponsors:   Spanish Breast Cancer Research Group;   Eli Lilly and Company Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conclusion: The present study, confirms literature data about MRI accuracy in diagnosing HER2+ and triple negative tumors, but suggests caution in case of luminal tumors' evaluation.
Source: In Vivo - Category: Research Authors: Tags: Clinical Studies Source Type: research
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (phar...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news
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