The Ministry of Public Health’s Pharmacy and Drug Control Department has issued a clarification regarding the drug Larotrectinib, commercially known as Vitrakvi for the treatment of some types of cancer.
The circular comes in the light of media reports regarding the US Food and Drug Administration’s (FDA) approval of the drug and exaggerations about its benefits. “The drug works in an innovative way by hindering the growth of the tumours that result from a rare genetic disorder (genetic mutilation) that causes some cases of cancer. Accordingly, this drug serves only a limited category of patients. The drug got a quick approval of US FDA, which is a procedure followed in dealing with the drugs that work in an innovative method, or could be a basis for promising future treatment. The US FDA approval followed a study conducted on 55 patients with 12 of them under 18 years and having the rare neurotrophic receptor tyrosine kinase (NTRK) gene fusion cancers. The response for the drug throughout the first nine months was good with results in 73% of the treated patients. Then it started to diminish gradually reaching 39% of the patients after the first year. “The most significant and common side effects observed on the patients that had used the medication include nausea, vomiting, fatigue, elevated liver enzymes, dizziness, diarrhoea and constipation. The Pharmacy and Drug Control Department follows up the latest scientific updates related to the drugs and methods of treatment and works to make the patients have access to effective and safe medications and methods of treatment,” the statement added.
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