The targeted drug Selpercatinib received accelerated approval from the FDA and is potentially beneficial for all cancer types, as long as they are RET gene fusion-positive solid tumours. It is up to 84% effective in some patients with non-small cell lung cancer!
On 21 September, the US FDA granted accelerated approval for Selpercatinib for the treatment of adult patients with locally advanced or metastatic solid tumours carrying a RET gene fusion, requiring that the patient's disease has progressed following previous treatment or that there are no other treatment options with better efficacy.
This approval is based on efficacy data from the LIBRETTO-001 trial, which enrolled 41 patients with solid tumours with RET gene fusions (excluding non-small cell lung cancer and thyroid cancer).
The results showed that Selpercatinib was 44% effective in all enrolled populations, with 4.9% of patients experiencing complete tumour disappearance and 39% experiencing substantial tumour disappearance. The average duration of efficacy was 24.5 months.
The cancers treated effectively were pancreatic adenocarcinoma, colorectal cancer, salivary gland cancer, cancer of unknown origin, breast cancer, soft tissue sarcoma, bronchial carcinoid tumour, ovarian cancer, small bowel cancer and bile duct cancer.
In 11 patients with adenocarcinoma of the pancreas, 55% had substantial tumour shrinkage and the duration of treatment ranged from 2.5 months to 38.3 months;
In 10 patients with colorectal cancer, 20% had substantial tumour shrinkage with duration of treatment ranging from 5.6 months to 13.3 months
in 4 patients with salivary gland carcinoma, 50% had substantial tumour shrinkage with duration of treatment ranging from 5.7 months to 28.8 months
substantial tumour shrinkage in one of three patients with cancer of unknown primary focus, with a duration of efficacy of 9.2 months.
Selpercatinib, alias LOXO-292, is a highly effective selective RET inhibitor that was granted accelerated approval by the FDA back in May 2020 for its outstanding efficacy in the treatment of non-small cell lung and thyroid cancers with RET gene fusions.
And on 21 September, the FDA also routinely approved Selpercatinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with RET gene fusion.
This routine approval was based on efficacy data in 316 patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer. Of the 69 patients who had not received prior treatment, 84% had substantial tumour disappearance and efficacy lasted an average of 20.2 months; of the 247 patients who had received prior platinum-based chemotherapy, 61% had substantial tumour reduction and efficacy lasted an average of 28.6 months.
Common side effects of Selpercatinib treatment include oedema, diarrhoea, fatigue, dry mouth, hypertension, abdominal pain, constipation, skin rash, nausea and headache.
