Adagrasib KRAS-G12C Inhibitor Approved by FDA

Mirati Therapeutics Adagrasib Approved Lung Cancer Medication

Adagrasib is the newest oral drug-inhibitor treatment for non-small cell lung cancer for patients with the KRAS-G12C gene mutation. The company Mirati Therapeutics gained approval for the drug, from the FDA, for use on adults with a specific KRAS-G12C mutation.

“The FDA approval of Krazati is a positive development for thousands of patients with KRAS-G12C mutations, including the approximately 14% of patients with NSCLC (non-small cell lung cancer) adenocarcinomas histology that harbor a KRAS-G12C mutation. Mirati is thrilled to make Krazati available in a tablet formulation to patients in the US with advanced NSCLC who have progressed beyond a first-line treatment for the historically difficult-to-treat KRAS mutation,” said David Meek, chief executive officer, of Mirati Therapeutics, Inc, in a press release.

The advanced approval of the drug was based on the high objective response rate and the average duration of the response being between 8.5 and 18.5 months. The verification and description of a clinical benefit in a confirmatory trial are also needed to continue approval of the drug. The treatment is only used on NSCLC patients who have tried other systemic treatments before or concurrently with adagrasib.

How Does Adagrasib Treat Non–Small Cell Lung Cancer?

Adagrasib—prescribed at 600 mg orally twice a day—targets non-small cell lung cancer (NSCLC) by grabbing onto the KRAS mutation, putting it into an inactive form, and stopping the mutation from signaling to continue abnormal cell growth. The drug is essentially stopping the mutation from being able to grow and entering a stage of non-progression. NSCLC is the most prevalent form of lung cancer in the United States, which is why the approval of adagrasib is bringing hope to doctors looking for more treatment options.

NSCLC’s prevalence can be attributed to the little to no symptoms in the early stages of cancer growth. By the time cancer has grown to cause symptoms of cough, shortness of breath, weight loss, etc., cancer has metastasized, or moved to other parts of the body. Altogether, one-third of lung cancer diagnoses happen during stage III with varying life expectancies. With the introduction of oral medications such as adagrasib and sotorasib, treatments targeting late-stage lung cancer have shown a significant reduction in mortality.

Adagrasib vs Sotorasib Cancer Treatment

Adagrasib is the latest NSCLC drug approved by the FDA, but sotorasib was approved first in May 2021. The two drugs are similar in ways, such as they both target the KRAS-G12C mutation of NSCLC, are drugs taken orally, and have both been shown to have disease control in their respective clinical trials. There are some discernable differences too. Sotorasib, sold under the brand name Lumakras by Amgen Inc., is dosed at 960 mg once per day and is to target solid tumors. Adagrasib can potentially reach the central nervous system (CNS), which is important since up to 42 percent of those with KRAS-mutated NSCLC have CNS metastases at their initial diagnosis. The drug half-life of adagrasib is 23 hours, and sotorasib is 5 hours, so adagrasib stays in the patients’ system for longer. Before or concurrently with either of these drugs, patients can also try chemotherapy and immunotherapy as treatments.

What is the KRAS Gene?

The Kirsten rat sarcoma viral oncogene homolog (KRAS) gene is a type of mutation of an oncogene or gene which may later become a tumor cell. The gene makes a protein called K-ras, which has the ability to control cell growth, maturation, and death. To slow down or stop a KRAS gene, you will need its inhibitor. Adagrasib and sotorasib are two known KRAS-G12C inhibitors that have clinical trials as evidence of their success. The inhibitor’s role is vital in treatment to slow down or stop the growth of cancer cells. With the KRAS-G12C mutation being one of the most common KRAS gene, the two drugs have become viable options for those affected by KRAS-infected NSCLC.

What’s Next for Adagrasib and Mirati Therapeutics?

Now that adagrasib and Mirati Therapeutics have their FDA approval; they can look into doing more clinical trials and research into what combination of drugs and treatments or dosages can help slow or stop NSCLC with KRAS-G12C. Mirati Therapeutics is currently looking into the treatment of advanced NSCLC with the usage of adagrasib, but also in combination with other forms of cancer treatments. Their Expanded Access Program (EAP), with adagrasib, is looking for patients with KRAS-G12C mutated cancers who have CNS metastases. If you are looking into options for treatment, there are other lung cancer and mesothelioma clinical trials that may apply to you.

The Lung Cancer Center understands the difficulties of finding treatment options for lung cancers. We are here to provide you with the most accurate and up-to-date information regarding new treatment options and clinical trials which may apply to your cancer. To have your case evaluated, consider using our absolutely free case evaluation to see if you are eligible for a settlement.