The US FDA recently has granted accelerated approval to larotrectinib for adult and pediatric patients with certain solid tumors. The safety and efficacy of the drug was evaluated in 55 patients which includes 12 patients under the age of 18. The results showed that 73% of the patients had responded within the initial six months of therapy. However, the response rate gradually decreased to 39% during the first year.
The drug, Larotrectinib has several side effects including fatigue, nausea, dizziness, vomiting, constipation, and diarrhea. The serious side effects include neurotoxicity, hepatotoxicity, and embryo-fetal toxicity. After the approval, Oman Ministry of Health issued a clarification on the US FDA’s approval highlighting the issue of small sample size with higher side effects. Source: Times of Oman, Omanobserver
