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Approval of Osimertinib and Necitumumab Increases Lung Cancer Treatment Options

December 28, 2015, by NCI Staff

Last month, the FDA approved two drugs that inhibit the activity of the epidermal growth factor receptor, or EGFR, for the treatment of patients with advanced lung cancer.

Credit: Wikimedia Commons

Last month, the Food and Drug Administration (FDA) approved two targeted therapies for patients with advanced non-small cell lung cancer (NSCLC).

The agency approved osimertinib (Tagrisso™) for patients who have developed the epidermal growth factor receptor (EGFR) T790M mutation in their tumors after prior treatment with an EGFR-targeted therapy, and necitumumab (Portrazza™), in combination with standard chemotherapy drugs, for the initial treatment of patients with metastatic squamous NSCLC.

Although both drugs target the EGFR gene, to be eligible to receive osimertinib, patients must have the EGFR T790M mutation, while all patients with squamous NSCLC are eligible to receive necitumumab.

Osimertinib, part of a class of drugs known as tyrosine kinase inhibitors, received an accelerated approval based on results from two single-arm clinical trials that collectively enrolled 411 patients. All patients in the trials had advanced NSCLC with tumors that harbored the EGFR T790M mutation and whose disease had gotten worse after they were treated with an EGFR-blocking drug.

In both trials, a complete or partial reduction in tumor size was seen in approximately 60 percent of patients. Diarrhea and skin and nail conditions, including rash, were among the most common side effects in patients treated with osimertinib. Serious adverse events included inflammation and scarring in the lungs (interstitial lung disease).

In conjunction with the osimertinib approval, the agency also approved a companion diagnostic test, the cobas EGFR Mutation Test v2, to test patient’s tumors for the presence of the T790M mutation.

“The majority of patients develop progression of their disease eventually after being treated with an EGFR-targeted kinase inhibitor,” explained Shakun Malik, M.D., of NCI’s Division of Cancer Treatment and Diagnosis.

Patients whose tumors progress after receiving these drugs have no other approved options, except for non-targeted chemotherapy, Dr. Malik noted. The T790M mutation is a common resistance mutation in such patients, she continued, so osimertinib’s accelerated approval “meets an important clinical need.”

Phase III trials that confirm osimertinib improves outcomes such as progression-free and overall survival must be completed for the drug to receive regular approval.

Necitumumab, a monoclonal antibody, was approved for use in combination with two other standard chemotherapy drugs, gemcitabine and cisplatin, as an initial treatment of patients with advanced squamous NSCLC.

The necitumumab approval was based on the results of a large randomized clinical trial that enrolled nearly 1,100 patients with advanced squamous NSCLC.

Patients treated with necitumumab along with gemcitabine and cisplatin had a modest improvement in median overall survival compared with patients who received cisplatin and gemcitabine alone: 11.5 months versus 9.9 months.

Common side effects associated with necitumumab include skin rash and magnesium deficiency (hypomagnesemia). The FDA also required the drug’s label to include a black box warning to alert clinicians and patients to the risk of cardiac arrest and sudden death associated with necitumumab treatment.

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