(RxWiki News) Changes to a protein known as EGFR can result in lung cancer. The medication Tarceva (erlotinib) is one of two drugs that target EGFR as a means of treating lung cancer. The use of Tarceva has just been expanded.
The US Food and Drug Administration (FDA) has approved Tarceva tablets for the initial treatment of metastatic (has spread) non-small cell lung cancer (NSCLC) tumors with EGFR mutations that have been detected by a new test, which the FDA has also approved.
The approval is based on a clinical trial which demonstrated Tarceva offered NSCLC patients more time before their disease got worse (progression-free survival) compared to chemotherapy.
Results from this trial showed that Tarceva doubled progression-free survival.
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One of the problems with personalized medicine is accurately detecting genetic mutations. The approval of the cobas EGFR test provides the sort of precision assessment needed to utilize targeted therapies such as Tarceva.
“Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations,” said Hal Barron, MD, chief medical officer and head of Roche Global Product Development, the company that developed the test and manufactures Tarceva.
“People with this type of lung cancer now have the option to use a personalized medicine as their initial treatment to help them live longer without their disease worsening," Dr. Barron said in a press release.
Tarceva is already approved in the US to treat patients with advanced NSCLC who have previously undergone chemotherapy.
The EURTAC study, which provided data for this latest approval, involved 174 NSCLC patients who were randomly assigned to receive either Tarcevo or a platinum-based chemotherapy.
The cobas EGFR Mutation test was used in the study to confirm specific EGFR mutations (exon 19 deletion or exon 21 [L858R] substitution).
The researchers found that Tarceva-treated patients had progression-free survival of 10.2 months compared to 5.2 months for patients treated with chemotherapy.
The most common adverse events among individuals taking Tarceva were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite.
Tarceva is currently available and costs roughly $6,200 for 30 tablets.
Roche is based in Basel, Switzerland.