304 North Cardinal St.
Dorchester Center, MA 02124
Product Name: Sotoxen
Generic Name: Sotorasib
Strength: 120 mg
Volume: 56 tablets
Manufacturer: Everest Pharmaceutical
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Sotoxen-120mg-Sotorasib, Amgen, a biopharmaceutical company, has developed an innovative KRAS inhibitor called Sotoxen. This inhibitor specifically targets the KRAS protein’s G12C mutation, responsible for various cancers such as NSCLC, colorectal cancer, and appendix cancer. Sotoxen has shown promising results in patients with advanced solid tumors carrying the KRAS p.G12C mutation. In particular, it demonstrated notable anticancer activity in a subgroup of NSCLC patients. These findings indicate that Sotoxen could be an effective treatment option for patients with KRAS p.G12C–mutated cancers. 
Sotoxen-120mg-Sotorasib is a targeted therapy used to treat a specific type of lung cancer called KRAS G12C-mutated non-small cell lung cancer (NSCLC) in adults. It can only be given to patients who have already received at least one prior systemic therapy. The medication has a moderate duration of action and should be taken daily. Patients should be aware of the potential risks associated with the treatment, which include hepatotoxicity, interstitial lung disease, and pneumonitis. Patients should also avoid breastfeeding during treatment and for up to one week after the last dose. The medication is marketed under the brand names Lumakras and Lumykras and is approved for treating specific types of cancer with a specific mutation. Clinical trials are underway to explore its effectiveness in treating other types of KRAS G12C-mutated cancers, including in combination with immunotherapy and chemotherapy. 
Sotoxen-120mg-Sotorasib is a cancer treatment that targets the cysteine residue in KRAS G12C mutations, which impairs GTP hydrolysis, preventing the protein from being inactive. This mutation is present in 13% of non-small cell lung cancer, 3% of colorectal and appendix cancer, and 1-3% of solid tumors. Sotorasib binds covalently to the inactive GDP-bound state of the K-Ras protein, locking it in its inactive state. This prevents K-Ras from cycling to its active GTP-bound form, which is essential for activating downstream signaling pathways. Sotorasib disrupts these pathways, preventing cancer cells from proliferating and promoting their death through apoptosis. Its targeted mechanism allows for selective inhibition of the mutant K-Ras protein while minimizing interaction with the wild-type protein, reducing potential side effects compared to traditional chemotherapy.
The recommended dosage of Sotorasib (Lumakras/Lumykras) is 960 mg orally, once daily, until disease progression or unacceptable toxicity. This translates to:
• Eight 120 mg tablets orally, once daily
• Three 320 mg tablets orally, once daily
It can be taken with or without food.
In some cases, the dosage of Sotorasib may need to be adjusted based on individual factors and potential side effects. Here are some potential scenarios:
• Hepatotoxicity (liver damage):
The Code Break 100 trial found that 70% of people with NSCLC experienced side effects, including diarrhea, muscle or bone pain, and nausea. Although most were mild, 25% experienced serious side effects and one had a life-threatening one. There were no treatment-related deaths, but one patient died from interstitial lung disease caused by the treatment. For 22% of patients, side effects led to a pause, reduction, or both in sotorasib dose.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Sotorasib (Lumakras, Amgen) on May 28, 2021, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy.
This approval was based on the results of the CodeBreaK 100 clinical trial, a multicenter, single-arm, open-label study that evaluated the efficacy and safety of Sotorasib in patients with locally advanced or metastatic NSCLC with KRAS G12C mutations. The trial demonstrated that Sotorasib:
The FDA granted Sotorasib Orphan Drug Designation for the treatment of KRAS G12C-mutated NSCLC on May 1, 2019, and received Breakthrough Therapy Designation on December 7, 2020.
However, it is important to note that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against Sotorasib’s approval in March 2023 due to concerns about the data supporting its efficacy. This vote does not change the FDA’s current approval of Sotorasib, but it may impact future decisions about the drug.