Astra Zeneca's latest lung cancer drug receives green light from FDA
Tagrisso is indicated for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has worsened after treatment with other EGFR-blocking therapy.
“Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “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.”
Additionally, the FDA green-lighted a companion diagnostic test to be used in the detection of the kind of EGFR resistance mutation that Tagrisso targets.
"The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” Dr. Alberto Gutierrez said. Gutierrez is the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Tagrisso was tested on 411 patients in two tests. Results showed the tumors of 57 percent of patients in the first study and 61 percent of patients in the second study shrank completely or partially.
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