Vientiane, Laos – October 12, 2024 – BigBear Pharma, a leading biopharmaceutical company focused on the development and commercialization of innovative cancer treatments, announced that Encorafenib has received approval from the Lao Ministry of Health.
Approved Drug
Encorafenib is a small molecule BRAF inhibitor that targets a key enzyme in the MAPK signaling pathway. This pathway is involved in many different cancers, including melanoma and colorectal cancer. The trade name approved in Laos is BRATODX, with Lao registration number: 09L1201/24.
Indications
1. Melanoma
Encorafenib in combination with Binimetinib is indicated for the treatment of adult patients with unresectable or metastatic BRAF V600E/K mutation-positive melanoma.
2. Colorectal cancer (CRC)
Encorafenib in combination with Cetuximab and the mFOLFOX6 regimen (fluorouracil, leucovorin, oxaliplatin) is indicated for the first-line treatment of BRAF V600E mutation-positive metastatic colorectal cancer (accelerated approval).
In combination with Cetuximab, it is indicated for the treatment of adult patients with BRAF V600E mutation-positive metastatic colorectal cancer who have failed prior therapy.
3. Non-small cell lung cancer (NSCLC)
Encorafenib in combination with Binimetinib is indicated for the treatment of adult patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer.
Dosage and Administration
1. Melanoma treatment
Before starting treatment with Encorafenib, the presence of the BRAF V600E or V600K mutation in tumor samples must be confirmed.
Recommended dose: 450 mg orally once daily, to be used in combination with Binimetinib.
2. Colorectal cancer treatment
Before initiating treatment with Encorafenib, the presence of the BRAF V600E mutation in tumor samples must be verified.
Recommended dose: 300 mg orally once daily, recommended to be used in combination with Cetuximab.
3. Non-small cell lung cancer treatment
Before treatment with Encorafenib, the presence of the BRAF V600E mutation should be confirmed in tumor or plasma samples.
Recommended dose: 450 mg orally once daily, recommended to be used in combination with Binimetinib.
Adverse Reactions
During treatment with Encorafenib, patients may experience the following adverse reactions:
1. Melanoma (in combination with Binimetinib)
Common adverse reactions: Some patients may experience fatigue, nausea, vomiting, abdominal pain, or joint pain.
Serious adverse reactions: A small number of patients may develop cardiomyopathy, hemorrhage, QT prolongation, or uveitis.
2. Colorectal cancer (in combination with Cetuximab ± chemotherapy)
Common adverse reactions: Patients may experience peripheral neuropathy, diarrhea, rash, or bleeding.
Serious adverse reactions: Very few patients may develop gastrointestinal perforation or elevated liver enzymes.
3. Non-small cell lung cancer (in combination with Binimetinib)
Common adverse reactions: Patients may experience fatigue, nausea, diarrhea, or musculoskeletal pain.
Serious adverse reactions: A small number of patients may experience serious conditions such as intracranial hemorrhage or myocardial infarction.
About BigBear Pharmaceuticals
BigBear Pharmaceuticals, headquartered in Vientiane, the capital of Laos, is committed to the research, development, production, and sale of pharmaceutical products, providing high-quality, safe, and effective medicines. BigBear Pharmaceuticals has established a strong reputation in the Lao pharmaceutical market through its outstanding expertise and innovation, and actively participates in international pharmaceutical cooperation and exchange.
