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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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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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Non-chemotherapy lymphoma treatment may provide durable remission
Fifty four percent of evaluable patients with DLBCL attained a substantial tumour reduction with the five-drug regimen, trial data shows.
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Novel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
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Innovative radioligand manufacturing facility inaugurated
Following advancements at a similar European facility, the new manufacturing facility in the US is set to produce lead-212 radioligand therapies.
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First-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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Advancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
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Innovating small molecule injectables: market forecast to 2033
Key trends in the global small molecule injectable drugs market up to 2033 include advancements in technology, drug delivery systems and fast-track approvals of new drug formulations, research predicts.
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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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AstraZeneca immunotherapy could boost lung cancer survival
Over half of patients were alive three years post-treatment with the monoclonal antibody (mAb) in AstraZeneca’s Phase III trial, data shows.
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Innovative nanocage promises sustainable cancer drug delivery
The unique system offers a targeted approach to deliver cancer drugs to tumours while helping to limit negative side effects.
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LBP-immunotherapy could benefit oncology patients
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
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Lignin-based drug delivery system may improve chemotherapeutics
A sustainable drug delivery method based on the biopolymer lignin could offer applications in anti-cancer therapies, research suggests.
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Progressing personalised cell therapies in oncology
Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.
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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
