U.S. FDA Gives Nod To Bristol-Myers Combo Therapy For Lung Cancer

Lung Cancer TherapyNon-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases. Lung cancer patients in advanced stages of the disease have received a new first-line treatment option. The U.S. Food and Drug Administration has approved Bristol Myers Squibb Co’s combination therapy for patients with lung cancer. The use of immunotherapy combination led to improvement in overall survival compared with chemotherapy alone.

The combination of Bristol’s treatments, Opdivo and Yervoy, is approved for treatment of NSCLC patients. This approval support came from positive findings from Part 1 of the phase III CheckMate 227 trial. It explored the nivolumab regimen in comparison with chemotherapy in patients with previously untreated NSCLC. Opdivo spurs the immune system to fight cancer and is one of the Bristol’s top-selling drugs but overtaken by Keytruda as industry’s immunoncology leader.

The study investigator Matthew D. Hellmann, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center said, “Patients with metastatic lung cancer remain in need of new treatment options that may provide durable responses.” “The results from the CheckMate 227 trial show that a dual immunotherapy approach offers a chance at long-term survival for appropriate patients with metastatic NSCLC,” he added.

This FDA approved combination of Opdivo plus Yervoy as a treatment for patients with NSCLC tumors that express programmed death-ligand one (PD-L1) on at least 1% of cells. The combination was specifically approved to treat advanced-stage NSCLC patients with PD-L1 positive tumors that don’t display EDFR mutations or ALK mutations.

“We continue to investigate novel combinations of therapy that may hold the potential to expand the therapeutic benefits of immunotherapy to patients with difficult to treat cancer or those who don’t respond, and look forward to evaluating the combination of Novartis’ MEK inhibitor with our immunotherapies,” said Fouad Namouni. Opdivo is indicated for treatment of NSCLC patients with progression on or after platinum-based chemotherapy.

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