news
Will ESR1-mutated breast cancer treatment gain approval?
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
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Breast cancer
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NICE guidance recommends olaparib for breast and prostate cancers
PARP inhibitor olaparib has been recommended in NICE’s final draft guidance for early breast cancer and advanced prostate cancer.
news
MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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Diagnostic approval facilitates more cancer patients treatment
The US FDA has approved Roche’s companion diagnostic test which identifies low HER2 expression in metastatic breast cancer, increasing pool of patients eligible for treatment with antibody drug conjugate Enhertu.
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Novartis’ Kisqali® provides “unparalleled survival benefit” in breast cancer
A pooled exploratory analysis shows Kisqali® plus endocrine therapy adds a year to overall survival of patients with aggressive form of breast cancer.
podcasts
EPR Podcast Episode 14 – Breast cancer drug development – Markus Kosch, Daiichi Sankyo
What unmet need remains in breast cancer and how is drug development helping tackle these challenges? Tune in to this episode with Daiichi Sankyo to find out more.
news
CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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Early phase CGT trials: key design elements correlating to distinctive biological characteristics
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
news
EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
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Establishing precision medicine in Abu Dhabi
Work is underway to create a collaborative virtual research institute (VRI) to support the fundamental research and subsequent clinical translation of precision medicine in Abu Dhabi, as well as the United Arab Emirates more broadly. Here, European Pharmaceutical Review’s Hannah Balfour discusses the project with the Head of the new…
news
Ibrance improves survival in breast cancer patients
Certain breast cancer patients treated with Ibrance (palbociclib) and an aromatase inhibitor were significantly less likely to die than those treated with the inhibitor alone, according to real-world evidence.
news
Kisqali offers survival benefit for breast cancer patients, finds study
Analysis of HR+/HER2- patients treated in first-line with Kisqali plus fulvestrant demonstrated a significant OS benefit of nearly 16 months over fulvestrant alone.
news
Designed for success – new SNA vaccine proves highly effective in mice
A team of scientists has developed a spherical nucleic acid (SNA) vaccine, which has demonstrated high efficacy as a COVID-19 therapy, as well as an anti-cancer treatment in rodents.
news
Lynparza® significantly reduces risk of death in early breast cancer patients
Lynparza® (olaparib) is the first PARP inhibitor to demonstrate overall survival benefit in early breast cancer, according to new data.
