PHOSOTOR sotorasib tablets

[English Name] Sotorasib Tablets

[R&D Code] AMG510

[Genetic Target] KRAS G12C

[Specification] 120 mg × 112 tablets/box

[Manufacturer] State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

[Overview]

Sotorasib (AMG 510) is one of the first small-molecule inhibitors to successfully target KRAS and enter human clinical development; it specifically targets and inhibits KRAS proteins harboring the G12C mutation. Sotorasib specifically and irreversibly inhibits the pro-proliferative activity of the G12C-mutated KRAS protein by locking it into an inactive, GDP-bound state.

[Indications]

Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation, who have received at least one prior systemic therapy.

[Dosage and Administration]

Recommended Dosage: 960 mg orally once daily.

Take once daily, at approximately the same time each day.

May be taken with or without food.

Swallow tablets whole; do not chew, crush, or split the tablets.

[Adverse Reactions]

The most common adverse reactions (≥ 20%) are diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities (≥ 25%) are lymphopenia, decreased hemoglobin, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), hypocalcemia, increased alkaline phosphatase, increased urine protein, and hyponatremia.

[Contraindications] None

[Precautions]

Hepatotoxicity: Monitor liver function tests every 3 weeks during the first 3 months of treatment, and monthly thereafter as clinically indicated. Based on severity, withhold, reduce the dose of, or permanently discontinue LuciSot.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms. For suspected ILD/pneumonitis, immediately withhold LuciSot; if no other potential causes of ILD/pneumonitis are identified, permanently discontinue the drug. [Safety and Efficacy]

Sotorasib is the first KRAS G12C inhibitor to enter clinical development; it now holds the potential to become the first targeted therapy approved for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.

The marketing application for Sotorasib is based on positive results from the advanced NSCLC patient cohort in the Phase II CodeBreaK 100 study. These patients had previously experienced disease progression following treatment with chemotherapy and/or immunotherapy. The full results of this study were presented at the virtual 21st World Conference on Lung Cancer (WCLC) in 2020. The data demonstrated that, among patients with advanced NSCLC harboring the KRAS G12C mutation—who had progressed after prior treatment with chemotherapy and/or PD-1/PD-L1 immunotherapy—Sotorasib exhibited durable anti-tumor activity and a favorable benefit-risk profile: a confirmed objective response rate (ORR) of 37.1%, a disease control rate (DCR) of 80.6%, a median duration of response (DOR) of 10 months, and a median progression-free survival (PFS) of 6.8 months.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F) for short-term transport.

[Manufacturer Introduction]

The National Pharmaceutical Factory No. 2 of the Lao People's Democratic Republic (PHARMA 2 VIENTIANE)—hereinafter referred to as "Lao Pharma 2"—is a state-owned pharmaceutical enterprise in Laos, operating directly under the supervision of the Lao Ministry of Health. Established in the 1970s, Lao Pharma 2 boasts a history spanning over 40 years. It stands as the largest, oldest, and most comprehensive pharmaceutical manufacturing enterprise in Laos in terms of the variety of medicines produced.

Each year, Lao Pharma 2 supplies patients with a wide range of medications—totaling over 160 different products—including intravenous infusions, injectables, oral tablets, oral capsules, oral syrups, and ointments. Laos Second Pharmaceutical Factory keeps pace with the times, actively engaging in exploration and continuously introducing advanced foreign technologies. The company seeks breakthroughs in both manufacturing processes and pharmaceutical R&D to ensure that its research and production capabilities remain aligned with international standards. Currently, Laos Second Pharmaceutical Factory has successfully obtained ISO 9001:2008 certification for its manufacturing processes. The mission of Laos Second Pharmaceutical Factory is to provide high-quality, internationally benchmarked pharmaceutical products and services to an ever-growing number of customers and patients through continuous progress and proactive innovation.

Product Specifications

Product Name: Sotorasib 120mg * 112 Tablets/Box

Common Name: Sotorasib Tablets

Active Ingredient: Sotorasib

Dosage Form: Tablets

Specification: 120mg * 112 Tablets/Box

Manufacturer: National Second Pharmaceutical Factory, Lao People's Democratic Republic

Indications: Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a *KRAS* G12C mutation, who have received at least one prior systemic therapy.

Dosage and Administration: Recommended dosage: 960 mg orally once daily.

Take once daily, at approximately the same time each day.

May be taken with or without food.

Swallow the tablets whole; do not chew, crush, or break the tablets.