New Lung Cancer Treatment Approved

Posted on: November 13, 2015

Dr. Kasra Karamlou Oncologist and Hematologist at Diablo Valley Oncology

Dr. Kasra Karamlou Oncologist & Hematologist at Diablo Valley Oncology in the San Francisco Bay Area

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Tagrisso, an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). The FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that Tagrisso (osimertinib) is known to target. Tagrisso was granted expedited approval because the drug has clinical data proving that it creates a measurable change that predicts clinical benefit beyond what other drugs currently offer. In other words, in initial clinical trials the drug must show regression of the disease, which leads to reasonable probability that the patient lives longer. This accelerated approval provides patients with access to this new oral non-small cell lung cancer treatment before the final confirmatory clinical trials are completed. Tagrisso is approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy such as Tarceva or Afatinib. Cancerous cells can adapt and begin to block other targeted therapies or chemotherapies that have been given to the patient, thus limiting the effectiveness. Tagrisso specifically targets those EGFR T790M mutations, which have not previously had no effective treatment options available after initial EGFR-blocking therapies. This new drug is a targeted cancer therapy (immunotherapy) that will benefit patient’s whose EGFR gene has further mutated to block the effectiveness of other EGFR treatments. Two studies were completed involving a total of 411 non-small cell lung cancer patients who had a EGFR-mutation and whose disease worsened after other EGFR-blocking treatments. In these studies 57% and 61% of patients in each group experienced a complete or partial reduction in their tumor size, which is associated with a clinical benefit. To read the FDA’s press release, visit their website. To learn more about Dr. Kasra Karamlou visit his page. Tags: ,