gdc
BiomarkersFDA Approvals, News & Updates

Tabrecta Approved for NSCLC with MET Biomarker

In May 2020, the FDA approved Tabrecta, a new targeted therapy for the treatment of patients with metastatic non–small-cell lung cancer that is associated with the MET biomarker.
June 2020 Vol 6 No 3

On May 6, 2020, the FDA approved Tabrecta (capmatinib; from Novartis), an oral kinase inhibitor, for adults with metastatic (spreading) non–small-cell lung cancer (NSCLC).

To be able to receive Tabrecta, patients must be tested to identify this biomarker (or mutation). Therefore, on the same day, the FDA also approved the Foundation

One CDx assay as a diagnostic test for Tabrecta.

“Tabrecta is the first approval specifically for the treatment of patients with non–small-cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence.

The clinical trial that led to the approval of Tabrecta included patients with NSCLC and the MET biomarker; patients were not included if they had EGFR or ALK gene mutations.

Among the 28 patients who had never received treatment for NSCLC, the overall response was 68%, including 4% complete responses and 64% partial responses. Among the 69 patients who received previous therapy, 41% had a partial response to Tabrecta. Moreover, 47% of the patients who received Tabrecta as first treatment versus 32.1% of patients who had previously received other NSCLC therapy responded to Tabrecta.

The most common side effects with Tabrecta were rash, nausea, fatigue, vomiting, shortness of breath, and reduced appetite. The serious side effects included interstitial lung disease or pneumonitis.

Share this:

Recommended For You
Breast CancerFDA Approvals, News & Updates
Drug Watch: Recently FDA-Approved Breast Cancer Treatments
There are more treatment options available for breast cancer than ever before – and more are coming. Here’s an overview of the most recently approved medicines.
FDA Approvals, News & UpdatesLymphoma
FDA Approved Breyanzi, Novel Gene Therapy, for Large B-Cell Lymphoma
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
FDA Approvals, News & UpdatesFollicular LymphomaLymphoma
FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma
Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.
FDA Approvals, News & UpdatesFollicular Lymphoma
Yescarta First Gene Therapy Approved for Follicular Lymphoma
Yescarta is the first CAR T-cell therapy approved by the FDA for patients with follicular lymphoma. It uses the patient’s own genetically modified T-cells to fight the cancer.
Last modified: August 10, 2020

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country