The United States Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the treatment of lung cancer with the epidermal growth factor receptor (EGFR) T790M mutation.

The indication specifies that patients must have non-small cell lung cancer (NSCLC) that has progressed despite treatment with other approved agents that block the EGFR pathway. The diagnostic companion test that can determine whether a cancer has the EGFR T790M mutation, referred to as the cobas EGFR Mutation Test v2, was also approved. A sample of cancer must undergo testing for the EGFR T790M mutation prior to a patient receiving treatment with Tagrisso.

Lung cancer is the number one cause of cancer-related deaths in the United States.  Research identifying specific molecular and genetic components of a patient’s cancer cells has led to the discovery of new therapeutic agents that target and treat lung cancers based on their individual characteristics.

The EGFR is involved in cellular replication and growth. A mutation within the EGFR can lead to the development and spread of cancer cells. Patients with cancer that has an EGFR mutation often respond well to EGFR inhibitors – agents that block the effects of the mutated EGFR. However, patients with the EGFR T790M mutation tend to either not respond, or become quickly resistant to treatment with the currently approved EGFR inhibitors.

Tagrisso is an agent that specifically targets the EGFR T790M mutation, reducing the growth and spread of the cancer cells. The latest results demonstrating the effectiveness of Tagrisso included 2 clinical trials that involved 411 patients with advanced NSCLC who had the EGFR T790M mutation. Their cancer had progressed following treatment with a standard EGFR inhibitor. All patients were treated with Tagrisso.

  • Approximately 60% of the patients in both trials experienced a complete or partial reduction in the size of their cancer (objective responses).
  • The most common side effects were diarrhea, and skin and nail conditions.

Longer follow-up from these and other ongoing confirmatory studies evaluating Tagrisso among this patient population are awaited.

In the FDA news release announcing the approval of Tagrisso, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research stated, “Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving. This approval provides a new treatment for patients who test positive for the EGFR resistance mutation, T790M, and is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated.”

Reference: United States Food and Drug Administration (FDA). News release. FDA approves new pill to treat certain patients with non-small cell lung cancer. Available at: Accessed November 13, 2015.

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