The FDA has approved the first targeted therapy for a lung cancer mutation that was previously thought to be drug-resistant.

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August 20, 2021: Recently in May, 2021 Lumakras (sotorasib) was approved by the US Food and Drug Administration as the first treatment for adult patients with non-small cell lung cancer who have undergone at least one prior systemic therapy and whose tumours have a specific type of genetic mutation called KRAS G12C. This is the first targeted therapy approved for malignancies with any KRAS mutation, which accounts for about 25% of mutations in non-small cell lung cancers. In non-small cell lung tumours, KRAS G12C mutations account for roughly 13% of all mutations.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”

The genetic abnormalities that cause lung cancer, the most prevalent cancer type with the greatest fatality rate, can be roughly classified. KRAS is a mutation that affects a collection of genes involved in cell development and division.

In a study of 124 patients with KRAS G12C-mutated non-small cell lung cancer who had progressed after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, researchers looked at the efficacy of Lumakras. The objective response rate (the percentage of patients whose tumours are eradicated or decreased) and the duration of response were the two main outcomes assessed. The objective response rate was 36%, with 58 percent of patients reporting a six-month or longer duration of response.

The 960 mg dose was approved based on available clinical evidence as well as pharmacokinetic and pharmacodynamic modelling that supported the dose. The government is demanding a postmarketing trial as part of the evaluation for this accelerated approval to see if a lower dose will have a similar therapeutic effect.

Diarrhea, musculoskeletal pain, nausea, exhaustion, liver damage, and cough are the most prevalent Lumakras adverse effects. Lumakras should be avoided if patients exhibit symptoms of interstitial lung disease, and should be stopped completely if the disease is diagnosed. Prior to starting and while using Lumakras, health care practitioners should evaluate a patient’s liver function tests. Lumakras should be withheld, dose lowered, or fully terminated if a patient develops liver damage. While taking Lumakras, patients should avoid taking acid-reducing medications, drugs that induce or are substrates for certain liver enzymes, and drugs that are P-glycoprotein substrates.

Lumakras was approved through the FDA’s Accelerated Approval pathway, which allows the agency to approve medications for serious illnesses where there is an unmet medical need and the treatment has been shown to have particular side effects that are fairly likely to predict a clinical benefit to patients. More research is needed to confirm and define Lumakras’ potential clinical advantages.

This application received Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA.

Lumakras was also designated as an Orphan Drug, which gives financial incentives to help and stimulate the development of treatments for rare disorders.

Project Orbis, an FDA Oncology Center of Excellence effort, was used to perform this review. Project Orbis creates a mechanism for worldwide partners to submit and review oncology medications at the same time. FDA worked with the Therapeutic Goods Administration (TGA) of Australia, the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and the Medicines and Healthcare Products Regulatory Agency on this review (MHRA; United Kingdom). The other regulatory bodies are still reviewing the applications.

Amgen Inc. received FDA approval for Lumakras.

Along with Lumakras, the FDA has approved the QIAGEN therascreen KRAS RGQ PCR kit (approved by QIAGEN GmbH) and the Guardant360 CDx (certified by Guardant Health, Inc.) as Lumakras companion diagnostics. To assess if Lumakras is an appropriate treatment for patients, the QIAGEN GmbH test analyses tumour tissue and the Guardant Health, Inc. test analyses plasma specimens. If no mutation is found in a plasma sample, the tumour of the patient should be evaluated.

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