When was tarceva developed

Results from the open-label trial were originally published in Lancet Oncology in Gefitinib was originally approved for second- and third-line treatment of NSCLC by the FDA in as part of an accelerated approval process based on a tumor response rate-a surrogate endpoint. The FDA withdrew the approval of the drug in after post-marketing studies failed to show an overall survival benefit of patients taking gefitinib.

Afatinib, developed by Boehringer Ingelheim, also has a companion diagnostic being developed in parallel. This labeling supplement is based on the results of the IUNO trial, a randomized, double-blind, placebo-controlled, trial of erlotinib administered as maintenance therapy in patients with advanced NSCLC who had not experienced disease progression or unacceptable toxicity during four cycles of platinum-based first-line chemotherapy.

Patients whose tumors harbored activating EGFR mutations exon 19 deletions or exon 21 LR mutations were excluded from this trial.

Patients were randomized to receive erlotinib or placebo orally once daily erlotinib, placebo until disease progression or unacceptable toxicity. The multicentre study is being conducted by Genentech in patients in the US, and will determine whether the addition of erlotinib to carboplatin chemotherapy is able to improve the duration of patient survival. Enrolment for this trial was completed in July An independent Data Monitoring Committee DMC has since reviewed the data from the trial and concluded that there are no safety or efficacy concerns that would warrant stopping the trial.

However, the DMC did recommend stopping erlotinib at the time of disease progression or at the start of second-line therapy. Enrolment into this study was completed in September , with approximately patients. Roche has confirmed that the study woulde has confirmed that the study would be included in the alliance's potential regulatory submission for front-line therapy in chemotherapy-naive patients in the US. Data from the trial is expected in the second half of OSI has opened two additional phase Ib studies to examine the potential of erlotinib in combination with carboplatin and paclitaxel in one study and gemcitabine and cisplatin in the other.

A phase I study of erlotinib is also being conducted in patients with lung cancer in Japan.