FDA Approves Gilotrif for Patients with Late Stage Non-Small Cell Lung Cancer

By: Taylor


According to the latest news from the United States Food and Drug sector the FDA has given nod to Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations. Lung cancer is one of the major causes of cancer-related death among men and women in the United States.

The approved drug Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.

While detailing about the approval of the drug, Dr. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research says “Today’s approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments”

Moving on the same line Dr. Jorge Gomez, medical director of the thoracic oncology program at Mount Sinai Medical Center in New York City says “This drug represents a new important alternative to standard chemotherapy in the 10 to 15 percent of lung cancer patients who have EGFR mutations,” He also pointed out that “it is the first drug to be developed and approved for patients selected for EGFR mutations”.

The FDA’s approval of the therascreen EGFR RGQ PCR Kit is based on data from the clinical study used to support Gilotrif’s approval. Tumor samples from NSCLC participants in the clinical trial helped to validate the test’s use for detecting EGFR mutations in this patient population. Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumors harbored EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin. Participants receiving Gilotrif had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy.

What is Gilotrif?

Gilotrif is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has certain types of abnormal epidermal growth factor receptor (EGFR) genes, and who have not had previous treatment for cancer that has spread to other parts of the body. The safety and efficacy of the product is yet to be established in children and infants.

Some of the side-effects of the drug are:

Diarrhea
Skin reactions
Lung or breathing problems
Liver problems
Eye related problems
Heart problems
Rashes
Mouth sores
Nail infection
Dry skin
Acne
Decreased appetite
Itching

For more information visit: http://www.unsafedrugs.com/fda-approves-gilotrif-patients-late-stage-non-small-cell-lung-cancer/

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