Regulatory Focus™ > News Articles > Newly-Approved Companion Diagnostic Promises Personalized Therapy for Lung Cancer Patients

Newly-Approved Companion Diagnostic Promises Personalized Therapy for Lung Cancer Patients

Posted 15 May 2013 | By Alexander Gaffney, RAC

US regulators on Tuesday announced the approval of the US' first companion diagnostic test to detect a gene mutation associated with a type of lung cancer, giving lung cancer patients a similar diagnostic tool now available to patients with breast cancer.


The product, approved 14 May 2013, is known as the Cobas EGFR Mutation Test, and acts as a companion diagnostic test to the already-approved cancer drug Tarceva. The drug's manufacturer, Astellas, wrote in a statement that the test could be a breakthrough for lung cancer patients.

"Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations," said Hal Barron, chief medical officer and head of Genentech Global Product Development. Genentech co-markets the drug on behalf of Astellas. "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."

The test could also be of great benefit to Tarceva itself. An October 2012 Untitled Letter sent to Genentech by FDA's Office of Prescription Drug Promotion chided it for having promoted the drug as being more effective than it actually was in studies.

FDA said one presentation of data in particular seemed to imply Tarceva alone was responsible for a 3.7-month extension in overall survival, when studies actually showed Tarceva was only responsible for approximately 12 days of that extension. FDA alleged that the claim was therefore misleading.

Personalized Benefit

But if Genentech and Astellas are now able to dial in and target their product to consumers who actually have the EGFR genetic mutation for which Tarceva is believed to be especially beneficial, it may soon be able to increase those 12 days on average to even greater benefits.

FDA's announcement on 14 May 2013 seems to agree with that theory. "The approval of the Cobas EGFR Mutation Test will allow physicians to identify non-small cell lung cancer (NSCLC) patients who are candidates for receiving Tarceva as first line therapy," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health (CDRH). "Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient."  

Regulators said that NSCLC patients who were identified as having the mutation and treated with Tarceva lived on average for 10.4 months, compared to 5.4 months for those who received a standard two-drug chemotherapy regimen.

Lunc cancer kills an estimated 160,000 patients in the US each year, of which approximately 85% involve NSCLC.

Read FDA's statement here.

Read Astellas' statement here.

See the drug's updated labeling here.

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