news
CHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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Breast cancer
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Antibody-drug conjugates: paving the future of oncology clinical development
Dr Mark Rutstein, Senior Vice President, Head of Oncology Clinical Development at Daiichi Sankyo, highlights key data about the company’s antibody-drug conjugate (ADC) being investigated for breast and lung cancer, and shares insight into why ADCs could replace current standards of care in oncology.
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Targeting tumours with novel radiopharmaceuticals
In this exclusive Q&A, Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape and why radiopharmaceutical therapeutics have significant potential in oncology.
news
CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
news
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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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PARP inhibitor olaparib has been recommended in NICE’s final draft guidance for early breast cancer and advanced prostate cancer.
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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.
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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.
