Published May 7, 2020

Lung Cancer Drug Tabrecta Approved By The FDA — New Hope For People With a Specific Biomarker

The FDA's approval of Tabrecta marks a historic step in treatment for patients battling aggressive lung cancer. Researchers say this is just the beginning.

Shelby Black

Details

Tabrecta For Lung Cancer

Tabrecta has been approved by the FDA for the treatment of non-small cell lung cancer (NSCLC) in people who also have a specific biomarker called METex14
Clinical trials of Tabrecta found that nearly 70 percent participants who had not been treated for NSCLC before saw tumor shrinkage
The drug will be available to both previously treated patients as well as untreated patients

An interesting new treatment option now exist for 3-4% of lung cancer patients. The Food and Drug Administration (FDA) approved the first of it’s targeted therapy called Tabrecta. It’s an oral drug for adults with non-small cell lung cancer (NSCLC) that has spread throughout the body.

The drug gained approval based on a clinical trial which found 68 percent of participants who had never gone through treatment for NSCLC saw tumor shrinkage. For other participants who had been treated for NSCLC before, 41 percent saw positive results from Tabrecta. The drug treats specific gene mutation METex14 which is associated with the disease, and blocks a protein that drives metastatic NSCLC in patients. According to Jeff Legos, Senior Vice President and Global Program Head of Novartis, 3 to 4 percent of newly diagnosed NSCLC patients contain the gene mutation, but represent a “unique patient population” as they are also impacted by other comorbidities.

“Another example of how biology trumps all personalized therapy at it best,” says Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital. “We started 23 years ago in lung cancer with EGFR inhibitors and now are sequencing nearly all tumors to identify molecular drivers which we can can target more specific and less targeted drugs. We will start to move these agents to the earliest stages of the disease.”

What Is NSCLC?

NSCLC is the most common form of lung cancer , with up to 85 percent of lung cancers being NSCLC. The disease is when malignant cancer cells form in the tissues of the lung, and squamous cell carcinoma, adenocarcinoma and large cell carcinoma are all subtypes of NSCLC. Adenocarcinoma is predominantly found in current or former smokers. Treatment options for this type of lung cancer have included surgery, postoperative chemotherapy, and radiation. However, with the approval of Tabrecta, patients will have even more access to treatment options.

Dr. Geoffrey Oxnard, a thoracic oncologist at Dana-Farber Cancer Institute, breaks down the anatomy of lung cancer

Immunotherapy For NSCLC

Before the approval of Tabrecta, clinical trials had been developed in order to decide whether immunotherapy treatments, which harvest the body's own immune system to fight off cancer, can also help treat patients battling NSCLC, and the evidence was promising. In 2018, the FDA approved the first course of Keytruda, an immunotherapy drug for the treatment of NSCLC when combined with chemotherapy. The new Keytruda-chemo combo approval was based on findings from a trial, which showed an improved overall survival rate in people with NSCLC who were treated with the combination compared to people who were treated with just chemotherapy by increasing the average person's survival without progression of the disease from 4.8 months with chemo alone to 6.4 months.

Dr. Brendon Stiles, a thoracic surgeon at Weill Cornell Medical Center, says immunotherapy has changed the game for lung cancer.

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