Tarceva and EGFR Mutation Test get US FDA Approval

By Sridhar Nadamuni , May 15, 2013 10:16 AM EDT

The FDA approved Tarceva for its fourth use and the third use for lung cancer.

Tarceva was first approved in November 2004 for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. The FDA approved Tarceva on April 16, 2010, for maintenance therapy of patients with locally advanced or metastatic NSCLC resistant to even four cycles of platinum-based first-line chemotherapy.

Metastatic refers to cancer that has already spread to other parts of the body. Non-small cell lung cancer (NSCLC) usually grows and spreads more slowly than small cell lung cancer, with different types found in an outer area, or in the center of the lung next to an air tube

Lung cancer is the leading cause of cancer-related death among men and women, and NSCLC is the most common type, with almost 86 percent of all lung cancers. According to the National Cancer Institute, of an estimated 228,190 new cases of lung cancer this year, there will be 159,480 deaths this year.
Genentech, a member of the Roche Group (RHHBY, ROG) has received the FDA approval for Tarceva tablets used in the initial treatment of people with metastatic non-small cell lung cancer involving certain epidermal growth factor receptor (EGFR) activating mutations. GFR (epidermal growth factor receptor) exists on the cell surface and is activated by binding certain molecules. The FDA also gave the go-ahead for the cobas® EGFR Mutation Test, which was developed by Roche and validated in the key EURopean TArceva vs. Chemotherapy (EURTAC) study.

The  EURTAC study evaluated the first-line use of Tarceva versus platinum-based chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC.

In the EURTAC study, Tarceva treatment extended life in patients without worsening their disease (10.4 months) compared to patients on chemotherapy (5.2 months). The safety profile for Tarceva in the EURTAC study was no different than the previous studies of Tarceva in NSCLC.

Activating epidermal growth factor receptor (EGFR) mutations constitute the first target of specific drugs called tyrosine kinase inhibitors (TKIs) clinically for the personalized treatment of advanced non-small cell lung cancer (NSCLC) patients. EGFR-TKIs reporting a significant improvement in progression-free survival (PFS) and overall response rate (ORR) in at least three randomized phase III studies investigating the role of two EGFR-TKIs inhibitors, gefitinib and erlotinib, as first-line treatment compared with standard platinum-based chemotherapy, in patients affected by advanced NSCLC harboring EGFR activating mutations.

The (EURTAC) study is the first trial with a TKI targeting the European population affected by advanced NSCLC involving activating EGFR mutations.

"Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations," Hal Barron, M.D., chief medical officer and head of Genentech Global Product Development, said in a press release. "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."

"With this approval, more patients across all lines of therapy have access to Tarceva," said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma Inc. "This new indication is emblematic of Astellas' commitment to continue our development efforts in lung cancer and precision medicine."

In the study, tumor shrinkage was observed in 65 percent of patients treated with Tarceva and 16 percent of patients treated with chemotherapy. The most common adverse effects seen were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite.

The cobas EGFR Mutation Test 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), according to the FDA release. The safety and effectiveness of the cobas EGFR Mutation Test was based on clinical data showing that, on average, NSCLC patients with specific types of EGFR mutations lived without their disease progressing for 10.4 months when they received Tarceva treatment, compared to 5.4 months for those who received a standard two-drug chemotherapy regimen, according to FDA reviewers.

"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," said 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. "Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient."

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