FDA Approves Oncomine Dx Targeted Detection Therapy: Can detect BRAF gene mutations

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The FDA approved Tafinar and Mekinist in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive BRAF V600 mutations.

In 2015, the FDA awarded a breakthrough therapy for the combination of these two drugs for the treatment of patients with non-small cell lung cancer with a poor prognosis of BRAF V600E mutation. In April of the same year, the EU approved the combination of darafini and trimetinib.

The FDA also approved Oncomine Dx Targeted Detection, a next-generation sequencing (NGS) test that detects BRAF, ROS1 and EGFR gene mutations.

"Standard chemotherapy is not optimistic for the treatment of patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer, so targeted therapy is imminent," said Bruno Strigini, CEO of Novartis Oncology, at a news conference.

FDA批准新疗法:治疗BRAF突变非小细胞肺癌

The FDA approved Tafinar and Mekinist in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive BRAF V600 mutations.

In 2015, the FDA awarded a breakthrough therapy for the combination of these two drugs for the treatment of patients with non-small cell lung cancer with a poor prognosis of BRAF V600E mutation. In April of the same year, the EU approved the combination of darafini and trimetinib.

The FDA also approved Oncomine Dx Targeted Detection, a next-generation sequencing (NGS) test that detects BRAF, ROS1 and EGFR gene mutations.

"Standard chemotherapy is not optimistic for the treatment of patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer, so targeted therapy is imminent," said Bruno Strigini, CEO of Novartis Oncology, at a news conference.

"The combination of darafini and trimetinib has made BRAF V600E the fourth genomic biomarker for metastatic non-small cell lung cancer, with the first three being EGFR, ALK and ROS1." From Dana Bruce Johnson, chief researcher and chief clinical researcher at the Farn Cancer Institute, said, “This is an important milestone in the field of lung cancer, which will allow us to better understand what is the genetic drive of cancer and find effective targets for these biomarkers. Targeted treatment options."

The approval was based on a three-group cohort, multicenter, non-randomized, open-label study that included patients with stage IV non-small cell lung cancer.

In this phase II study, 36 patients who had not received treatment were enrolled in a group, and 57 patients who received treatment were enrolled. Two groups of patients took 150 mg of dalafenib twice a day, and 2 mg of trimetinib. . The objective response rate (ORR) assessed by the investigator was the primary indicator of the study. The second group of patients underwent at least one platinum-based chemotherapy before enrollment, and one-third of them underwent at least 2 treatment cycles.

At a median follow-up of 9 months, the objective response rate in the first group was 61.1%, and 68% of the patients did not progress. When the drug was approved, the median duration of progression or progression-free survival was not obtained for this group of patients. However, 59% of patients who had a remission after treatment had a response time of more than 6 months.

The objective response rate for the second group of patients was 63%. The researchers found that their remission after treatment was long-lasting, with a median duration of up to 12.6 months.

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