lucius luciencor encorafenib capsules

【Product Name】Encorafenib Capsules

【Other Name】Encorafenib

【English Name】Encorafenib Capsules

【Specification】75mg × 90 capsules/box

【Manufacturer】Lucius Pharmaceuticals (Laos) Co., Ltd.

【Laos FDA Registration No.】08L1184/24

Encorafenib is a medication used to treat melanoma and colorectal cancer. It belongs to a class of drugs known as BRAF inhibitors; it works by inhibiting the activity of a specific protein (the BRAF protein) to block cancer cell growth, thereby slowing disease progression. Encorafenib is widely used in clinical practice, offering new therapeutic opportunities for patients requiring targeted therapy.

Application of Encorafenib in Melanoma Treatment

Melanoma is a malignant tumor arising from melanocytes in the skin and mucous membranes. Early diagnosis and treatment are crucial. Encorafenib has been approved for the treatment of melanoma. When melanoma cells harbor BRAF V600E or V600K mutations, Encorafenib is recommended for use either as a monotherapy or in combination with a MEK inhibitor. Treatment with Encorafenib can prolong patient survival, slow disease progression, and improve overall quality of life.

Application of Encorafenib in Colorectal Cancer Treatment

Colorectal cancer is a common tumor of the digestive system, with a large number of people diagnosed worldwide each year. Encorafenib is also used in the treatment of colorectal cancer. When colorectal cancer cells harbor the BRAF V600E mutation, Encorafenib can be administered as a monotherapy or in combination with a MEK inhibitor. Encorafenib treatment regimens can extend patient survival and offer new hope to patients who previously lacked effective treatment options. 【Indications】

1. In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring a BRAF V600E mutation who have previously received systemic therapy.

2. In combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma harboring a BRAF V600E or V600K mutation.

Limitation of Use: Encorafenib is not indicated for the treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC.

【Dosage and Administration】

Recommended dosage for unresectable or metastatic melanoma with BRAF V600E or V600K mutation: The recommended dose of encorafenib is 450 mg (six 75 mg capsules) taken orally once daily in combination with binimetinib, until disease progression or unacceptable toxicity occurs. Please refer to the binimetinib prescribing information for the recommended binimetinib dosage.

Recommended dosage for metastatic colorectal cancer (CRC) with BRAF V600E mutation: The recommended dose of encorafenib is 300 mg (four 75 mg capsules) taken orally once daily in combination with cetuximab, until disease progression or unacceptable toxicity occurs. Please refer to the cetuximab prescribing information for the recommended cetuximab dosage.

【Side Effects】

New primary malignancies, hemorrhage, uveitis, QT prolongation.

The most common adverse reactions (>25%) associated with the combination of encorafenib and binimetinib are fatigue, nausea, vomiting, abdominal pain, and arthralgia.

Although encorafenib demonstrates good efficacy in cancer treatment, there are still side effects associated with its use. Common side effects include nausea, diarrhea, fatigue, and skin rash (urticaria). Patients should closely monitor their physical condition during encorafenib treatment and promptly report any discomfort to their doctor. Additionally, encorafenib may interact with other medications; therefore, you should consult a doctor and follow their advice before use.

Clinical Trial: Encorafenib plus binimetinib showed the highest PFS rate at the 5-year follow-up.

A total of 192 patients received encorafenib plus binimetinib, 191 received vemurafenib, and 194 received encorafenib alone. The median follow-up time for progression-free survival (PFS) was 40.8 months.

The median PFS was 14.9 months (95% CI, 11.0–20.2) for the encorafenib plus binimetinib group and 7.3 months (95% CI, 5.6–7.9) for the vemurafenib group (HR, 0.51; 95% CI, 0.40–0.67). The median PFS for the encorafenib-only group was 9.6 months (95% CI, 7.4–14.8).

At the 5-year mark, the PFS rate was 23% for the encorafenib plus binimetinib group, 10% for the vemurafenib group, and 19% for the encorafenib-only group.

Company Profile

Lucius Pharmaceuticals (Laos) Co., Ltd. (hereinafter referred to as Lucius Pharmaceuticals) is a modern, multinational, high-tech biopharmaceutical enterprise. It currently operates a global R&D center and collaborates with three top-tier industry research teams. Specializing in the development of complex chemical formulations and biological products, the company has achieved technological breakthroughs in key generic drugs. Lucius Pharmaceuticals has established itself as one of the world's leading companies in the R&D of patented generic drugs, earning a strong reputation and excellent market standing within the industry.

In 2020, Lucius Pharmaceuticals officially launched its Asia-Pacific strategy, investing heavily to build the "Asia-Pacific No. 1 Smart Factory" in Vientiane, Laos. Adhering to GMP production standards, the facility incorporates cutting-edge pharmaceutical equipment from China, the United States, and Germany, and features an international-standard high-end formulation workshop, boasting an annual generic drug production capacity exceeding 1.5 billion tablets. The company's product portfolio now encompasses over 200 categories—including treatments for oncology, cardiovascular conditions, hematological disorders, diabetes, and dermatological issues, as well as men's health and anti-aging products—with exports reaching more than 50 countries and regions across Europe, South America, Africa, the Middle East, India, Vietnam, and Nepal.

Lucius has established a pharmaceutical production facility in Laos that meets the country's highest standards. Following the commencement of operations at the Laos plant, the company aims to collaborate with ASEAN nations to accelerate its internationalization, strengthen global R&D partnerships, expand its product range, and enhance quality, all with the goal of becoming a leading global pharmaceutical enterprise.