Roche: FDA Approves First Gene Test Kit for Blood Samples from Non-Small Cell Lung Cancer (NSCLC)

Issuing time:2018-10-23 00:00

June 6, 2016 / BIO Valley BIOON / -- swiss drug giant Roche has announced that the US Food and Drug Administration (FDA) has approved Cobas EGFR Mutation  Test  V2 ( cobas  EGFR mutation detection kit v2, which is a blood-based, anti-cancer drug Tarceva ( Tarceva, generic name : erlotinib ), erlotinib) in the companion diagnostic kit.Notably, this is the first FDA-approved blood-based test for epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC) patients.) a genetic test kit for mutations.It is estimated that this type of mutation exists in 10-20 % of NSCLC cases.

Lung cancer is the leading cause of cancer death among men and women in the United States, although it is more common among men. The National Cancer Institute (NCI) estimates that in 2016, 22.12 million lung cancer cases are expected to be confirmed and 158000 deaths will occur.Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.During the development of NSCLC, a small amount of tumor DNA enters the patient's blood system, which enables detection of tumor-specific genetic mutations using blood samplesto make it possible.

The use of blood samples for tumor DNA testing is also known as "liquid biopsy" Biopsy).Alberto, FDA's Center for Equipment and Radiological Health  Gutierrez said that the approval of the liquid biopsy kit is of great significance for individualized and precise treatment, and liquid biopsy enables the clinician to minimize an invasive approach to identify patients with specific mutations in tumors will provide strong technical support for clinical practice in oncology.

Using Cobas EGFR Mutation  Test  V2 was detected in patients with specific NSCLC mutations ( exon 19 deletion or exon 21 L858R substitution mutation ) in the patient's blood sample, it will help identify which patients may benefit from the treatment of Tarceva.However, if such mutations are not detected in blood samples, a tumor biopsy should be performed to determine whether such NSCLC mutations exist in tumor tissue.If the blood test is positive, it could benefit a group of patients who are very ill or who are unable to provide a tumor sample for EGFR testing.

In a clinical study, patients with NSCLC were treated with Cobas EGFR Mutation  Test  V1 test confirmed EGFR exon 19 deletion mutation or L858R mutation in tumor biopsy samples, using Cobas EGFR Mutation  Test  The validity of this fluid biopsy was confirmed by V2 when tested for blood samples from patients.

Tarceva is a targeted anti-cancer drug that was approved by the FDA in 2004 for locally advanced or metastatic failure to receive at least one chemotherapy regimen treatment of NSCLC.In 2013, the FDA further approved Tarceva as first-line treatment for metastatic NSCLC with EGFR exon 19 deletion mutation or L858R replacement mutation.


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