Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
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The drug is the first treatment for desmoid tumours to be approved in the region.
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
The European approval of Koselugo was based on its ability to reduce inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1.
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
Forty percent of neurofibromatosis type 1 patients enrolled in the trial had a >20 percent reduction in tumour burden with cabozantinib.