Vientiane, Laos - November 20, 2023 - BigBear Pharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announced that Selpercatinib has received approval from the Lao Ministry of Health. It is marketed under the brand name SEPADX.
Indications for Selpercatinib
1. Non-Small Cell Lung Cancer (NSCLC)
For adults with locally advanced or metastatic RET fusion-positive NSCLC, as confirmed by an FDA-approved test.
2. Medullary Thyroid Cancer (MTC)
For adults and pediatric patients aged ≥2 years with advanced or metastatic RET mutation-positive MTC who require systemic therapy.
3. Thyroid Cancer
For adults and pediatric patients aged ≥2 years with radioactive iodine-refractory (if applicable) advanced or metastatic RET fusion-positive thyroid cancer.
4. Other RET Fusion-Positive Solid Tumors
For adults and pediatric patients aged ≥2 years with locally advanced or metastatic solid tumors (based on accelerated approval) that have progressed on prior treatment or for which no satisfactory alternative therapy exists.
Dosage and Administration for Selpercatinib
1. Adults and Adolescents ≥12 Years of Age
Body weight ≥50 kg:160 mg orally, twice daily.
Body weight;50 kg:120 mg orally, twice daily.
2. Children Aged 2-12 years
Dose adjusted by body surface area (BSA):
BSA 0.33-0.65 m²: 40 mg orally, three times daily.
BSA 0.66-1.08 m²: 80 mg orally, twice daily.
BSA 1.09-1.52 m²: 120 mg orally, twice daily.
BSA ≥1.53 m²: 160 mg orally, twice daily.
Adverse Reactions of Selpercatinib
1. Common Adverse Reactions (≥25%)
Adults: Edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache.
Children: Musculoskeletal pain, diarrhea, headache, nausea, vomiting, COVID-19 infection, abdominal pain, pyrexia, hemorrhage.
2. Laboratory Abnormalities (≥5%)
Adults: Lymphopenia, elevated ALT/AST, hyponatremia, hypocalcemia.
Children: Hypocalcemia, decreased hemoglobin, neutropenia.
3. Serious Adverse Reactions
Hepatotoxicity, interstitial lung disease, QT interval prolongation, bleeding events, hypersensitivity reactions.
Warnings and Precautions for Selpercatinib
1. Hepatotoxicity
Monitor ALT/AST regularly during treatment; adjust dosage based on toxicity grade.
2. Interstitial Lung Disease (ILD)
Withhold treatment immediately and evaluate in patients presenting with new or worsening respiratory symptoms.
3. Hypertension
Control blood pressure before treatment initiation and monitor regularly during therapy.
4. QT Interval Prolongation
Monitor electrocardiograms and electrolytes periodically in high-risk patients (e.g., those with hypokalemia).
5. Bleeding Risk
Permanently discontinue in case of severe bleeding events.
6. Impaired Wound Healing
Withhold treatment for at least 7 days prior to surgery and for 2 weeks after major surgery.
