FDA Approves New Lung Cancer Diagnostic "Cobas EGFR Mutation Test"

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Main Category: Lung Cancer
Also Included In: Cancer / Oncology;??Medical Devices / Diagnostics
Article Date: 15 May 2013 - 2:00 PDT Current ratings for:
FDA Approves New Lung Cancer Diagnostic "Cobas EGFR Mutation Test"

The U.S. Food and Drug Administration (FDA) has approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).

Patients with such genetic mutations generally benefit from treatment with an anti-EGFR tyrosine kinase inhibitor, such as Roche's Tarceva (erlotinib).

The diagnostic test, manufactured by the Roche Molecular Systems in Pleasanton, California, will be used as a companion diagnostic for drug Tarceva, as a form of first-line treatment for patients with NSCLC whose cancers have spread to other parts of the body.

Tarceva (erlotinib), an oral lung cancer treatment, was officially licensed as first-line monotherapy for the treatment of patients with advanced forms of non-small cell lung cancer (NSCLC) with a certain mutation, saving them from up-front chemotherapy.

According to the National Cancer Institute, lung cancer is currently one of the leading causes of cancer-related deaths, with an anticipated 228,190 new cases of the cancer this year alone (and approximately 159,480 deaths). Each year in the U.S., lung cancer kills more individuals than prostate, colon, and breast cancers combined.

NSCLC is the most common form of lung cancer, accounting for about 85 percent of cases.

Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said:

"The approval of the cobas EGFR Mutation Test will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving Tarceva as first line therapy. Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient."

Clinical studies demonstrated the effectiveness of the cobas EGFR Mutation Test. Patients with a specific type of EGFR mutation who received Tarceva treatment lived for 10.4 months without their disease progressing, as opposed to only 5.4 months for those who were only treated with standard two-drug chemotherapy regimen.

Those with the mutation were identified with the new diagnostic test.

On April 16, 2010, the drug Tarceva was approved by the FDA for patients suffering from locally advanced or metastatic NSCLC. It was originally approved, in 2004, for the treatment of locally advanced NSCLC following the failure of a chemotherapy regiment.

Written by Joseph Nordqvist

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FDA Approves New Silicone Gel-Filled Breast Implant

The U.S. Food and Drug Administration (FDA) has approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, the company is required to conduct post-approval studies to assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes. ?

Silicone gel-filled breast implants are implanted under breast tissue or chest muscle for breast augmentation or reconstruction. They have a silicone outer shell that is filled with silicone gel and come in different sizes.??

Breast reconstruction may refer to a primary reconstruction to replace breast tissue that has been removed or revision surgery to correct the result of a primary reconstruction surgery. ?

The FDA based its approval of Sientra’s implant on 3 years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), reoperation, implant removal, an uneven appearance (asymmetry), and infection.?

Sientra’s post-approval studies will include:?

An additional 7 years of follow-up of the 1,788 clinical trial participants in their pre-market study ?A 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer?Five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.?

With the addition of Sientra’s approval, there are now three FDA-approved silicone gel-filled breast implants on the market in the U.S. ?

Silicone gel implants have generated a fair amount of controversy regarding their safety because of the question as to whether they can trigger certain connective tissue and autoimmune diseases. In 1992, the FDA restricted the use of silicone implants in order to evaluate whether they were indeed associated with autoimmune conditions. Clinical trials have continued and the data continues to indicate that the implants are safe.?????

It’s important to remember that breast implants are not lifetime devices and long-term monitoring is imperative. ?

Reference:?

FDA approves new silicone gel-filled breast implant [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm?

Posted May 14, 2012

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