FDA Approves Tabrecta, First Targeted Therapy for NSCLC

Non-Small-Cell Lung Cancer (NSCLC)The FDA has approved Tabrecta, Novartis for the treatment of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. NSCLC is the most common type of lung cancer with up to 90% of all lung cancer patients come under this category. It has a high risk of cancer cells spreading to other regions of the body.

Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research said, “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, which they didn’t have prior to today.”

Tabrecta has been approved for both untreated as well as previously treated patients, irrespective of their previous type of treatment. It is the first approved treatment for specifically target METex14 mutated metastatic NSCLC. With this approval, Novartis beats Pfizer Inc in the race to develop treatment for NSCLC. This approval has been based on the results of a clinical trial involving patients with NSCLC with mutations that led to MET exon 14 skipping, epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) and at least one measurable lesion.

The common side effects for patients taking Tabrecta include leg swelling, shortness of breath, fatigue, nausea, vomiting and decreased appetite. Drugmakers like Novartis are increasing using biomarker-driven drugs for treatment of patients with rare tumors; only 3 to 4% of lung cancer patients have MET exon14 skipping mutation. Only about 4000-5000 patients are diagnosed with METex14 metastatic NSCLC each year in the United States.

The information shared in this blog is for educational purposes only.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.