MacroGenics seeks FDA approval for breast cancer treatment

MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news

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ConclusionThe results of the BELIS study support that trastuzumab SC can be safely administered at home by a HCP and all patients considered this setting as beneficial. HCPs consider the SC formulation as the quickest method to administer trastuzumab.Trial registrationEudraCT Identifier: 2013-000123-13. ClinicalTrials.gov Identifier: NCT01926886.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
Publication date: Available online 30 January 2020Source: Journal of Geriatric OncologyAuthor(s): Melissa Ruth Gannon, David Dodwell, Yasmin Jauhari, Kieran Horgan, Karen Clements, Jibby Medina, David Alan CromwellAbstractBackgroundClinical guidance on recommended treatment for older patients with breast cancer is often ambiguous, particularly in the context of comorbidities and poor functional status. Older patients, aged 70 years and over, account for a substantial proportion of women with breast cancer yet are underrepresented in randomized controlled trials. This paper investigates the initiation of adjuvant chemothe...
Source: Journal of Geriatric Oncology - Category: Cancer & Oncology Source Type: research
ConclusionsThe dual-targeting strategy developed in this study in conjunction with a potentially promising delivery vector for a synergistic combination therapy can overcome receptor heterogeneity, yielding significant improvements in the cytotoxicity and cellular uptake in BC cells.
Source: Pharmaceutical Research - Category: Drugs & Pharmacology Source Type: research
AbstractClinical progress in the field of HER2-positive breast cancer therapy has been dramatically improved by understanding of the immune regulatory mechanisms of tumor microenvironment. Passive immunotherapy utilizing recombinant monoclonal antibodies (mAbs), particularly trastuzumab and pertuzumab has proved to be an effective strategy in HER2-positive breast cancer treatment. However, resistance to mAb therapy and relapse of disease are still considered important challenges in clinical practice. There are increasing reports on the induction of cellular and humoral immune responses in HER2-positive breast cancer patien...
Source: Archivum Immunologiae et Therapiae Experimentalis - Category: Allergy & Immunology Source Type: research
MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
AbstractPurpose of ReviewThe phosphatidylinositol 3-kinase (PI3K) pathway is the most common aberrantly activated pathway in breast cancer, making it an attractive therapeutic target. In this review, we will discuss the rationale for targeting PI3K/AKT signaling and the development of PI3K/AKT inhibitors in breast cancer.Recent FindingsAlthough the initial clinical trials with pan-PI3K inhibitors were challenged by high toxicities and modest antitumor effect, there has been continued effort to develop agents more precisely targeting PI3K isoforms to improve therapeutic index. Alpelisib in combination with fulvestrant is no...
Source: Current Oncology Reports - Category: Cancer & Oncology Source Type: research
Conclusion: The bioactivity prediction shows that all compounds are active to moderately active. These positive results show that it could be further investigated and explored.
Source: Current Cancer Therapy Reviews - Category: Cancer & Oncology Source Type: research
In this study, Her2, MUC1, and a novel fusion structure were expressed in the seeds and hairy roots of transgenic plants appropriately. The mice groups were immunized either by feeding of transgenic seeds or hairy roots. All immunized groups showed a considerable rise in anti-glycoprotein serum IgG and IgA, and IFNɣ cytokine. However, the animals received chimeric protein showed significant higher immune responses in comparison to ones received one of these immunogen. The results indicated that the oral immunization of an animal model with transgenic plants could effectively elicit immune responses against two major ...
Source: Iranian Journal of Allergy, Asthma and Immunology - Category: Allergy & Immunology Authors: Tags: Iran J Allergy Asthma Immunol Source Type: research
urigliano G Abstract PURPOSE: FGFR1 gene is amplified in 14% of HR+/ HER2- breast cancer patients. Efficacy and safety of lucitanib, an inhibitor of VEGFR1-3, FGFR1-3 and PDGFRα/β, were assessed. EXPERIMENTAL DESIGN: HR+/ HER2- MBC patients received oral lucitanib in 3 centrally confirmed cohorts: 1) FGFR1 amplified, 2) FGFR1 non-amplified, 11q13 amplified, 3) FGFR1 and 11q13 non-amplified. Key inclusion criteria included ECOG PS 1 line of anti-cancer therapy, but
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
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