FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
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The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
Inauguration of the new facility supports BeiGene’s goal to develop affordable and accessible cancer treatments for patients globally.
The investigators hope that their new approach could lead to large-scale manufacturing of the CAR T cells for blood cancer patients.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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.
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…
Fifty four percent of evaluable patients with DLBCL attained a substantial tumour reduction with the five-drug regimen, trial data shows.
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
Following advancements at a similar European facility, the new manufacturing facility in the US is set to produce lead-212 radioligand therapies.
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.
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.
The updated, longer-term Phase II trial results suggest that the antibody therapy could offer a novel approach for treating advanced rectal cancer.
Over half of patients were alive three years post-treatment with the monoclonal antibody (mAb) in AstraZeneca’s Phase III trial, data shows.
The unique system offers a targeted approach to deliver cancer drugs to tumours while helping to limit negative side effects.