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NICE recommends innovative breast cancer drug
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
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Metastatic breast cancer
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MHRA authorisation is first endocrine therapy innovation in decades
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
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Innovation passport designation awarded to Pfizer and Arvinas
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
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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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Enhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from R&D at AstraZeneca, discuss the evolving nature of clinical innovation…
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Top biopharma firms report Q3 market capitalisation decline
The top 20 biopharma companies averaged a market capitalisation decline of $3.45 trillion in Q2 to $3.14 trillion in Q3 2022, says GlobalData.
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FDA Fast Track designation for photodynamic cancer therapy
REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
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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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Trodelvy® improves breast cancer progression-free survival, finds study
Trodelvy® (sacituzumab govitecan-hziy) was found to significantly reduce the risk of disease progression or death in certain breast cancer patients.
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CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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NICE approves breast cancer treatment through Cancer Drugs Fund
NICE has approved palbociclib through the Cancer Drugs Fund, meaning that women with advanced breast cancer who have already received hormone therapy will now be eligible for palbociclib on the NHS.
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Top 10 drugs by annual revenue in 2025
Researchers have revealed the top 10 drugs by annual revenue in 2025. Here, we investigate the indications that necessitate these treatments and the delivery systems they employ.
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Ogivri approved as the first biosimilar against certain breast and stomach cancers
The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumours overexpress the HER2 gene...
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FDA accepts regulatory submission for Lynparza in metastatic breast cancer
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer...
