Lumakras Approved as First Targeted Therapy for Drug Resistant KRAS G12C Lung Cancer Mutation

Lumakras Approved as First Targeted Therapy for Drug Resistant KRAS G12C Lung Cancer Mutation

May 28, 2021 – The U.S. FDA has granted accelerated approval to LumakrasTM (sotorasib), manufactured by Amgen, to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, in adults who have received at least one prior systemic therapy. Lumakras is the first and only targeted therapy to receive FDA approval for this indication. Because it received accelerated approval, continued approval may be contingent on verification and description of clinical benefit in confirmatory trials.

KRAS mutations affect the regulation of cell growth and division and are associated with a poor prognosis for patients diagnosed with lung cancer. Overall, they account for 25% of mutations in NSCLC, with KRAS G12C mutations accounting for approximately 13% of NSCLC mutations. Because KRAS mutations are often resistant to drug therapy, treatment options for cancer patients diagnosed with these mutations have been limited.

In a clinical trial, Lumakras delivered an objective response rate of 36% and a median duration of response (DoR) of 10 months. Of patients whose disease responded to treatment, 58% had a DoR of six months or more. A response was defined as a 30% or greater decrease in tumor size.

Recommended dosing is 960mg (eight 120mg tablets) taken by mouth once daily until disease progression or unacceptable toxicity occur. Lumakras can be dispersed in water for patients who have difficulty swallowing tablets. Dosage modifications may be required if the patient experiences an adverse reaction to Lumakras. If possible, the drug should not be coadministered with proton pump inhibitors or H₂ receptor antagonists, which are medications used to reduce stomach acid production. If treatment with acid-reducing agents cannot be avoided, Lumakras should be taken four hours before or 10 hours after administration of a local antacid.

Lumakras has launched at a wholesale acquisition cost of $17,900 per month.