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GSK's lung cancer drug granted orphan status by FDA

Wed 10 Dec 2025 07:18

(Sharecast News) - GSK's risvutatug rezetecan has received Orphan Drug Designation from US regulators for the treatment of small-cell lung cancer, the UK pharma group announced on Wednesday. This is the fifth regulatory designation for risvutatug rezetecan, which is being developed for treating a range of solid tumours, including lung, prostate and colorectal cancers.

The US Food and Drug Administration's ruling follows preliminary clinical data showing "durable responses" to the treatment in patients with extensive stage SCLC, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.

Extensive stage SCLC is associated with high rates of relapse, few treatment options and poor prognosis, with overall survival with standard-of-care treatments for relapsed ES-SCLC at just eight months.

The European Medicines Agency recently granted Orphan Drug Designation for risvutatug rezetecan for the treatment of pulmonary neuroendocrine carcinoma, a category of cancer that includes SCLC.

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