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FDA Approves Chemo-Free Combination Drugs for Lung Cancer

The FDA has approved a combination of drugs as first-line treatment for lung cancer. The combo includes ipilimumab (Yervoy, Bristol-Myers Squibb) and nivolumab (Opdivo, Bristol-Myers Squibb), which can treat patients with metastatic non-small cell lung cancer with tumors that express PD-LI (≥ 1%). The drugs are limited to lung cancer patients without the epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

A companion diagnostic device known as PD-L1 IHC 28-8 pharmDx was also approved by the FDA to help identify patients who are candidates for the combination treatment.

The FDA approval came after a randomized clinical trial was conducted in patients with recurrent or metastatic non-small cell lung cancer who had no prior anticancer treatment.

In the first stages of the trial, patients were assigned to receive a combination of nivolumab and ipilimumab or platinum-doublet chemotherapy. The median overall survival was found to be 17.1 months versus 14.9. The overall response rate was confirmed to be 36% and 30%.

The median response duration took 23.2 months for the group using nivolumab and ipilimumab, while the platinum-doublet-chemotherapy group took 6.2 months.

Patients on the nivolumab and ipilimumab showed adverse reactions including rash, fatigue, low appetite, diarrhea/colitis, musculoskeletal pain, pruritus, dyspnea, nausea, cough, and hepatitis.

The recommended dose for patients with metastatic non-small cell lung cancer is 3 mg/kg every two weeks for nivolumab and 1 mg/kg every six weeks for ipilimumab until the progression of the disease or if there’s unacceptable toxicity. The dose can also take up to 2 years for patients without disease progression.

Although the results of the study indicate there’s a new treatment option for metastatic non-small cell lung cancer, there’s a need for more research to point outpatients who can benefit from two immunotherapies, with a combination of immunotherapy and chemotherapy or with just one single agent.

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