Σάββατο, 14 Νοεμβρίου 2015

OSIMETRINIB APPROVED BY FDA FOR T790M EGFRm+ NSCLC

The U.S. Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non–small cell lung cancer (NSCLC). Osimertinib (Tagrisso) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse 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,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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 [osimertinib] had a significant effect on reducing tumor size in over half of patients who were treated.” 
Diagnostic Test Also Approved
Today, the FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that osimertinib is known to target. The newly approved version (v2) of the test adds the T790M point mutation to the clinically relevant mutations detected by the original cobas EGFR Mutation Test (v1). 
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The availability of the cobas EGFR Mutation Test v2 meets a need for the detection of this important EGFR gene mutation, which can alter treatment effectiveness.”
Clinical Study Results
The safety and efficacy of osimertinib were demonstrated in two multicenter, single-arm studies involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease worsened after treatment with an EGFR-blocking medication. In these two studies, 57% of patients in the first study and 61% of patients in the second study experienced a complete or partial reduction in their tumor size.
Continued approval for this indication may be contingent upon further confirmatory studies.
The most common side effects of osimertinib are diarrhea; skin and nail conditions such as dry skin; rash; and infection or redness around the fingernails. Osimertinib may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.

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