sotorasib

Sotorasib is indicated for the treatment of advanced non-small cell lung cancer (NSCLC) that has metastasized and harbors a KRAS p. G12C mutation. It is specifically prescribed for adult patients who have previously undergone at least one other form of systemic therapy.

According to Amgen’s Hazard Classification System, Sotorasib is classified as an Occupational Exposure Band 3 compound, with a recommended exposure limit of 20 µg/m3 – 100 µg/m3. It is advised to use local exhaust ventilation or work within a chemical hood when handling this compound. Additionally, it is recommended to wear shields and a full-face shield to prevent any contact with the eyes.

LUMAKRAS became the first KRASG12C inhibitor to be granted regulatory approval in the U.S. in May 2021, receiving accelerated approval. Since then, more than 15,000 patients globally have been treated with LUMAKRAS/LUMYKRAS through clinical development, early access programs, and commercial use.

The FDA granted accelerated approval to sotorasib in 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with KRAS G12C mutation. This approval was based on the results of the phase 2 CodeBreaK 100 trial (NCT03600883).

You may experience symptoms such as nausea, vomiting, diarrhea, constipation, muscle/joint pain, or tiredness. If any of these symptoms persist or worsen, please inform your doctor or pharmacist immediately.

Sotorasib binds irreversibly to the specific cysteine of KRASG12C, causing the protein to become inactive and preventing downstream signaling. This does not affect wild-type KRAS. Sotorasib effectively blocked KRAS signaling, inhibited cell growth, and induced apoptosis specifically in tumor cell lines with KRAS G12C mutation.

Sotorasib, the first inhibitor of KRAS G12C to be approved by regulatory authorities in the United States, received FDA accelerated approval in May 2021 based on data from the phase 2 CodeBreaK 100 trial (NCT03600883). This approval allows sotorasib to be used as a treatment for adult patients with KRAS G12C-mutated NSCLC who have undergone at least one prior systemic therapy.

Dosage for non-small cell lung cancer in adults is 960 milligrams (mg) per day. This can be taken as three 320 mg tablets or eight 120 mg tablets. Your doctor may modify the dosage based on your individual needs and tolerance.

Sotorasib demonstrated an overall response rate (ORR) of 41%, with a median duration of response (DoR) of 12.3 months. The progression-free survival (PFS) was 6.3 months, and the overall survival (OS) was 12.5 months, with a 2-year OS rate of 33%. Additionally, 23% of patients experienced long-term clinical benefit (PFS 12 months), regardless of PD-L1 expression levels, and a subset of patients with somatic STK11 and/or KEAP1 alterations also showed a favorable response.

It is crucial to comprehend that sotorasib operates differently from traditional chemotherapy drugs. Instead of directly attacking all rapidly dividing cells, it specifically targets cancer cells to inhibit their growth and prevent them from spreading.

As of February 22, 2022, a total of 174 patients received a daily dose of 960 mg of sotorasib. Among these patients, 48 were in phase I of the study and 126 were in phase II. The median duration of treatment was 5.6 months, ranging from 0.2 to 35.9 months. At the time of data cutoff, 13 patients were still undergoing treatment. The median number of prior lines of therapy for the patients was 2.0, ranging from 0 to 4 or more.

The median overall survival was 10.6 months (95% CI = 8.9-14.0 months) in the sotorasib group, compared to 11.3 months (95% CI = 9.0-14.9 months) in the docetaxel group. The hazard ratio was 1.01 (95% CI = 0.77-1.33, P = ).

Early findings suggest that Sotorasib has a reported ORR of 21% in advanced pancreatic cancer patients, while Adagrasib has a similar reported ORR of 22% in advanced colorectal cancer patients. These initial results appear to be promising.

If you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin, it is important to consult your doctor immediately as these may indicate a serious liver issue.

Symptoms to be taken seriously include sudden loss of vision, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights. Additionally, serious heart symptoms include fast, irregular, or pounding heartbeats, fluttering in the chest, shortness of breath, sudden dizziness, lightheadedness, or fainting.

KRAS is the most commonly mutated gene among the three human ras isoforms, with mutations found in 17% to 25% of all cancers. In colon cancer specifically, around 30% to 40% of cases have a KRAS mutation. These mutations in KRAS have been linked to a lower survival rate and more aggressive tumor growth in colon cancer patients.

Sotorasib is the first FDA-approved therapy that specifically targets the K-RAS mutation by blocking G12C, making it a breakthrough treatment for malignancies.

Sotorasib (Lumakras, Amgen) monotherapy received approval in 2021 for the treatment of KRAS G12C-driven, locally advanced, or metastatic non-small-cell lung cancer (NSCLC). Its antitumor activity and clinical efficacy were demonstrated through in vitro, preclinical, and clinical trial data.

Sotorasib is classified as an antineoplastic medication, which falls under the category of cancer medicines. Its mechanism of action involves disrupting the growth of cancer cells, leading to their eventual elimination. It is important to note that this medication can only be obtained with a valid prescription from your doctor.

To take Sotorasib, swallow 8 tablets (totaling 920 mg) once a day. Do not crush or break the tablets. You can take this medication with or without food, but make sure to take it at the same time every day.

Sotorasib specifically interacts with the cysteine residue found in KRAS G12C mutations, causing the protein to remain inactive. This cysteine residue is not found in the normal, wild type KRAS, ensuring that sotorasib does not have any unintended effects on other proteins.

Lumakras Prices, Coupons, and Patient Assistance Programs: Lumakras (sotorasib) is a medication used for Non-Small Cell Lung Cancer. The price of Lumakras oral tablet 120 mg is approximately $21,186 for a 240-tablet supply, which may vary depending on the pharmacy.

Yes, all Medicare prescription drug plans provide coverage for this drug.

Lumakras is typically listed on Tier 5 of Medicare prescription drug plans’ formulary, which usually entails higher medication costs as the tier increases.

Symptoms may include nausea, diarrhea, cough, liver problems, muscle, joint, or bone pain, tiredness, or abnormal blood tests.

Lumakras starts working immediately after the first dose, but it may take several weeks for it to have an impact on your NSCLC. Due to the mechanism of action, you may not feel any noticeable effects of the drug in your body.

Sotorasib (AMG-510) is a small molecule inhibitor that specifically targets KRAS G12C, an oncogenic mutation. In preclinical experiments, sotorasib effectively caused the regression of tumors with KRAS G12C mutations. Furthermore, clinical trials have shown its efficacy in treating non-small cell lung cancer (NSCLC).

Sotorasib, a specialty medication, is classified as a Limited Distribution Drug (LDD). This means that it can only be obtained from specialty pharmacies and is not available at retail pharmacies such as CVS or Walgreens.

According to a study presented at the 2022 European Society of Medical Oncology Congress, the survival rate with Lumakras was 24.8% at 12 months, compared to 10.1% with the chemotherapy agent docetaxel (Taxotere), at a median of 17.7 months.

Typically, stage 4 cancer has metastasized to various parts of the body, resulting in a life expectancy of a few weeks to a few months. However, there are rare instances where individuals may survive for several months or even a year, with or without treatment.

For complete Important Safety Information for LUMAKRAS, refer to page 3. Also, refer to the full Prescribing Information for LUMAKRAS. It is important to note that LUMAKRAS has the potential to cause hepatotoxicity, resulting in drug-induced liver injury and hepatitis.

If left untreated, the median survival rate is eight months, with a 30% chance of surviving for one year. However, patients who opt for surgical resection have a significantly higher median survival rate of 36 to 50 months, with a 5-year survival rate ranging from 36% to 67.8%. Despite the success of surgery, there is a 68% recurrence rate, with the lungs being the most common site of recurrence.

LUMAKRAS is utilized in the treatment of non-small cell lung cancer (NSCLC), which is caused by the abnormal protein KRAS G12C. This protein plays a role in cell growth, and LUMAKRAS works by binding to KRAS G12C and inhibiting its function in tumor cells.

The patients who received the 960-mg Lumakras dose had a 26% objective response rate, while only 6% of patients who received the 240-mg dose had a similar response rate. Additionally, the median progression-free survival for patients on the investigator’s choice was 2.2 months.

According to a study by Topalian et al. (CA209-003), patients with pretreated NSCLC who received two years of nivolumab treatment experienced a long-term benefit, with an estimated 5-year survival rate of 16%.