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Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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Colorectal cancer
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Big potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about…
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Biologic demonstrates durable tumour regression in rectal cancer
The updated, longer-term Phase II trial results suggest that the antibody therapy could offer a novel approach for treating advanced rectal cancer.
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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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Vaccine demonstrates benefit in delaying cancer relapse
Data from the Phase I trial showed that the cancer vaccine offered an 86 percent reduction in the risk of relapse or death in pancreatic and colorectal cancers.
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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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Takeda to license potential treatment for colorectal cancer
Takeda and HUTCHMED have entered into an exclusive licensing agreement, to develop tyrosine kinase inhibitor fruquintinib for colorectal cancer outside China.
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France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
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Advancing cell therapies – γδ T cells and the combination factor
In this Q&A, Bryan Kobel, Chief Executive Officer of TC Biopharm, discusses innovations in cell therapies, introducing the company’s work in gamma delta (γδ) T-cell technologies and his predictions for the future of cell therapy development.
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Photo-responsive nanoassemblies could enable precision cancer drug delivery
Researchers demonstrate a simple system using photo-cleavable prodrugs for the precise delivery of cancer treatment in mice.
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Could ‘drug factory’ beads help combat cancer?
New pre-clinical testing shows interleukin producing ‘drug factory’ implants can eliminate ovarian and colorectal cancer in mice.
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Lumakras™ displays positive results in Phase Ib cancer study
Lumakras™ (sotorasib) demonstrated effective response rates against non-small cell lung cancer and colorectal cancer in Phase Ib trial.
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First patient dosed with BioNTech’s mRNA-based immunotherapy
BioNTech expands clinical oncology portfolio with first patient dosed in Phase II trial of mRNA-based vaccine for colorectal cancer.
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Sotorasib plus panitumumab shows efficacy against colorectal cancer
Sotorasib combined with panitumumab displayed 27 percent response rate against colorectal cancer in Phase I/II trial.
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
