Indications:
1. Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
2. Adults and children aged 12 years and older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy (oral or injection);
3. Adults and children aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic treatment and are resistant to radioactive iodine therapy.
Clinical trial data:
Celpatinib is the world's first targeted drug specifically targeting RET gene mutations. It has been granted Orphan Drug Designation (ODD), Breakthrough Drug Designation (BTD), and Priority Review by the U.S. FDA. Celpatinib produced by Element Pharmaceuticals is the world's first generic drug.
Non-small cell lung cancer - Adult patients with RET fusion-positive NSCLC who received platinum chemotherapy: The objective response rate (ORR) of 105 patients participating in the clinical trial was 64%. Among patients who responded to treatment, 81% of patients had a response that lasted at least six months. The efficacy of 39 patients with RET fusion-positive NSCLC who had never received treatment was also evaluated, and the ORR of these patients was 84%. Among patients who responded to treatment, 58% of patients had a response that lasted at least six months.
RET-mutant medullary thyroid cancer --- Adults and children 12 years and older with RET-mutant thyroid cancer: 143 patients with RET mutations participated in the clinical trial. The ORR for 55 patients previously treated with cabozantinib and vandetanib was 69%. 76% of patients who responded to treatment had responses that lasted at least six months. The ORR for 88 patients with RET-mutant medullary thyroid cancer who had not been previously treated with cabozantinib and vandetanib was 73%, and 61% of patients who responded to treatment had responses that lasted at least six months. Adults and children 12 years and older with RET fusion-positive thyroid cancer: 19 patients with refractory RET fusion-positive thyroid cancer and 8 patients with refractory RET fusion-positive thyroid cancer who had not received any other treatment participated in the clinical trial. The ORR for the 19 patients who had been previously treated was 79%, and 87% of patients who responded to treatment had responses that lasted at least six months. The ORR for the 8 patients with RET fusion-positive thyroid cancer who had been treated only with radioactive iodine was 100%, and 75% of patients who responded to treatment had responses that lasted at least six months.
Dosage and Administration:
Orally twice a day (approximately every 12 hours). Recommended dose based on body weight: ① Less than 50kg: 120mg; ② 50kg and above: 160mg, until disease progression or unacceptable toxicity occurs. Swallow the capsule whole, do not crush or chew the capsule shell.
Do not miss any dose unless the next scheduled dose is missed by more than 6 hours. If vomiting occurs after taking the medicine, do not make up for it and take the next dose at the original interval.
Adverse reactions:
The most common adverse reactions include: increased liver enzyme levels; hyperglycemia; leukopenia; decreased blood albumin; hypocalcemia; dry mouth; diarrhea; increased creatinine; increased alkaline phosphatase; hypertension; fatigue; edema; thrombocytopenia; increased cholesterol; rash; hyponatremia and constipation.
