UPDATE : Friday, June 5, 2020
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Novartis' new drug for mutated lung cancer gets insurance coverage
  • By Kim Yun-mi
  • Published 2020.02.10 18:29
  • Updated 2020.02.10 18:29
  • comments 0

A combined modality therapy of Rafinlar (ingredient: dabrafenib) and Meqsel (ingredient: trametinib) for metastatic non-small-cell lung cancer patients confirmed with BRAF V600E mutation began to receive insurance benefits on Monday.

BRAF V600E is a specific mutation in the BRAF gene, which makes a protein involved in sending signals in cells and cell growth. This genetic mutation may increase the growth and spread of cancer cells.

Patients with benign metastatic non-small-cell lung cancer account for 1-3 percent of non-small-cell lung cancer patients worldwide.

The patients with BRAF mutation desperately needed a new treatment because they had shorter disease-free survival period and life span compared to other patients.

The approval was based on the results of a global phase-2 clinical study, considering the urgent treatment for patients with BRAF V600E mutation-benign non-small-cell lung cancer.

The study evaluated 78 patients in the Rafinlar monotherapy group (cohort A), 57 patients in the Rafinlar-Meqsel combination group (cohort B), and 36 patients who had no anticancer therapy history in the combined therapy (cohort C).

The result showed that the cohort C group showed more clinically significant data. The Rafinlar-Meqsel group took 150 milligrams of Rafinlar twice a day and two milligrams of Meqsel each day.

Objective response rate, the percentage of patients whose cancer shrinks after treatment, of the cohort C group was 64 percent, and the median duration of response was 10.4 months. The median progression-free survival -- the time of patients living with the disease but not worsen -- was 10.9 months, and the median overall survival was 24.6 months.

"Rafinlar-Meqsel therapy is the first combined modality and targeted therapy for BRAF V600E mutated metastatic non-small-cell lung cancer patients," Novartis Korea said.


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