-- Robert Preidt
FRIDAY, July 12 (HealthDay News) -- A new drug to treat advanced
lung cancer has been approved by the U.S. Food and Drug
Gilotrif (afatinib) is approved to treat patients with a
specific subtype of of non-small cell lung cancer (NSCLC). About 85
percent of lung cancers are NSCLC, making it the most common type
of lung cancer.
Gilotrif is approved to treat tumors that carry key deletions on
the epidermal growth factor receptor (EGFR) gene, long a target for
lung cancer therapeutics. Mutations in the EGFR gene are thought to
occur in about 10 percent of non-small cell lung cancers, and most
of those mutations are targeted by Gilotrif, the FDA said.
Experts were pleased with the drug's approval.
"This drug represents a new important alternative to standard chemotherapy in the 10 to 15 percent of lung cancer patients who have EGFR mutations," said Dr. Jorge Gomez, medical director of the thoracic oncology program at Mount Sinai Medical Center in New York City. The new medication "is the first drug to be developed and approved for patients selected for EGFR mutations," he pointed out.
Dr. Len Horovitz is a pulmonary specialist at Lenox Hill
Hospital in New York City. He explained that the "genetic
evaluation of lung cancer tissue has evolved so that newer
mutations can be targeted in treatment," and new drugs such as
Gilotrif "complement standard chemotherapy [and] give hope of
increased survival even in late stage lung cancer."
Gilotrif is in a class of cancer drug called tyrosine kinase
inhibitors. These drugs block proteins that promote the development
of cancerous cells.
According to the FDA, Gilotrif was approved alongside the
therascreen EGFR RGQ PCR Kit -- a companion diagnostic that helps
determine if a patient's lung cancer cells express these EGFR
Gilotrif's approval was based on a clinical study of 345
patients who were randomly assigned to receive either Gilotrif or
up to six cycles of the chemotherapy drugs pemetrexed and
cisplatin. Patients who received Gilotrif had a delay in tumor
growth (progression-free survival) that was more than four months
longer than those who received chemotherapy. However, there was no
statistically significant difference in overall survival between
the two groups of patients, the FDA said.
Along with common side effects such as itching, bladder
inflammation, low blood potassium levels, fever, and eye
inflammation, serious side effects associated with Gilotrif include
diarrhea that can result in kidney failure and severe dehydration,
severe rash, lung inflammation and liver toxicity, the agency
Gomez said the speed of the FDA's approval was encouraging.
"The development and approval of afatinib was significantly shorter [than that seen with prior lung cancer drugs] and reflects a clear focus toward individualizing lung cancer therapy to specific patients who are most likely to have a significant benefit," he said. "This is a clear push toward more personalized medicine."
Dr. Richard Pazdur, director of the Office of Hematology and
Oncology Products in the FDA's Center for Drug Evaluation and
In an agency statement, he said that Gilotrif's approval shows
"how a greater understanding of the underlying molecular pathways
of a disease can lead to the development of targeted
In May, the FDA approved Tarceva (erlotinib) for treatment of
patients with non-small cell lung cancer. That drug was approved at
the same as the cobas EGFR Mutation Test, a companion diagnostic to
identify patients with tumors having the EGFR gene mutations.
Gilotrif is marketed by Boehringer Ingelheim Pharmaceuticals
Inc. of Ridgefield, Conn. The companion diagnostic test is marketed
The U.S. National Cancer Institute has more about
non-small cell lung cancer.
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