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FDA Approvals, News & UpdatesLung CancerNewsworthy

Vizimpro a New First Treatment for Patients with Metastatic Lung Cancer and EGFR Mutations

November 2018 Volume 4 – Lung Cancer

In September 2018, the FDA approved a new targeted therapy, Vizimpro (dacomitinib; from Pfizer) tablets, for use as the first treatment (first-line treatment) in patients with metastatic (progressing to other organs) non–small-cell lung cancer (NSCLC) that is associated with specific mutations known as EGFR exon 19 deletion or exon 21 L858R substitution mutations (gene alterations). Patients should only use Vizimpro after a specific FDA-approved test identifies that their lung cancer has EGFR exon 19 deletion or exon 21 L858R substitution mutations.

Vizimpro joins several other tyrosine kinase inhibitors that specifically target patients with NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution mutations. In April 2018, the FDA approved the targeted drug Tagrisso (osimertinib; from AstraZeneca) for patients with NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution mutation. And in January this year, the FDA approved another tyrosine kinase inhibitor, Gilotrif (afatinib; from Boehringer Ingelheim), for all patients with this type of lung cancer. The FDA approved Vizimpro as first-line treatment for patients with this type of lung cancer based on the clinical trial known as ARCHER 1050, which included 452 patients with unresectable (can’t be removed by surgery), metastatic NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution mutations. The study compared the treatment results with Vizimpro and with Iressa (gefitinib; from AstraZeneca), another tyrosine kinase inhibitor that was approved by the FDA in 2015 for first-line treatment of patients with NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution.

The average time of survival without cancer progression was 14.7 months among patients who received Vizimpro versus 9.2 months in patients who received Iressa, a significant improvement in the time of survival without the cancer progressing, although there was no improvement in the overall duration of survival for patients with this type of lung cancer survival. Vizimpro is associated with the risk for lung infection, diarrhea, and skin reactions.

Overall, 27% of patients in the study had serious adverse events, and some patients discontinued treatment because of side effects. The most common reasons for treatment discontinuation were diarrhea and lung infection.

In August 2018, the FDA approved the immunotherapy Opdivo (nivolumab; from Bristol-Myers Squibb) for the treatment of patients with metastatic (spreading) small-cell lung cancer that progressed after platinum-based chemotherapy and at least 1 other therapy. Opdivo was previously approved by the FDA for patients with non–small-cell lung cancer, the most common type of lung cancer.

With this new approval, Opdivo became the first immunotherapy available for patients with small-cell lung cancer, which has fewer treatment options.

This approval was based on results from a clinical trial of 109 patients with or without PD-1 expression who had metastatic small-cell lung cancer that progressed after chemotherapy and at least 1 other therapy.

Overall, in 13 patients with small-cell lung cancer, the cancer responded to treatment with Opdivo, and the responses lasted between 6 months to more than 18 months. This new approval for Opdivo now offers patients with small-cell lung cancer access to immunotherapy, an important addition to the treatment options available for patients with this type of lung cancer.

The side effects with Opdivo in this study were similar to those seen in other studies, and 10% of patients discontinued treatment because of side effects.

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Last modified: December 11, 2018

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