The U.S. Food and Drug Administration approved Capmatinib to treat the non-small cell lung cancer (NSCLC) in adult patients. Capmatinib is the first FDA-approved treatment for NSCLC with specific mutations that result in mesenchymal-epithelial transition (MET) exon 14 skipping.
Nearly all patients were with tumour samples, which were tested for mutations leading to MET exon 14 skipping with local tests and proved using F1CDx.
In NSCLC, malignant cancer cells appear in the tissues of the lung. In this cancer, there’s a high probability that the cancer cells will spread to other body parts. Mutations resulting in MET exon 14 skipping appear in 3-4% of lung cancer patients.
Capmatinib is a kinase inhibitor, which acts by inhibiting the primary enzyme that helps to stop the growth of tumour cells.
The FDA approved Capmatinib based on the clinical trial outcomes enrolling NSCLC patients with mutations.
In the clinical trial, patients were given Capmatinib 400 mg through oral route two times a day until unacceptable toxicity or disease progression. The primary efficiency result was overall response rate (ORR). Another efficiency result was the duration of response (DOR). The efficiency population involved sixty-nine earlier treated patients and twenty-eight patients who never received therapy for NSCLC.
The ORR for twenty-eight patients was 68%- 4% with a complete response and 64% with a partial response. The ORR was 41% for sixty-nine patients all with partial response.
Among the patients who were responding who had received therapy for NSCLC, 47% had a DOR for 12 months or more as compared to the 32.1% of the responding patients who were earlier treated.
Capmatinib was approved as per the Accelerated Approval pathway that approves drugs, which are meant for the treatment of the severe or life-threatening disorder. It usually offers an advantage over existing therapies.
| Source: | FDA |
| Link to the source: | https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-aggressive-form-lung-cancer
[Last accessed on: 10 December, 2020] |
| Original title of article: | FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer |
| Translated by: |
