ERLOTINIB APPROVED AS MAINTENANCE THERAPY OF ADVANCED NSCLC IN PATIENTS WHOSE DISEASE HAS NOT PROGRESSED AFTER 4 CYCLES OF CHEMOTERAPY

April 20, 2010 — The US Food and Drug Administration (FDA) has approved an expanded indication for erlotinib (Tarceva, OSI Pharmaceuticals Inc and Genentech, Inc) for the first-line maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after 4 cycles of platinum-based chemotherapy.

The drug was approved regardless of a 12-to-1 vote against the approval at an FDA Oncologic Drugs Advisory Committee meeting in December 2009, in which panel members cited the modest benefits of earlier erlotinib use.

"We are delighted that lung cancer patients and their physicians will have the option of beginning Tarceva therapy in the first-line maintenance setting. We believe that Tarceva, as the only medicine approved in the maintenance setting for the squamous and non-squamous forms of NSCLC, offers a valuable treatment option for these patients," said Colin Goddard, PhD, chief executive officer of OSI Pharmaceuticals, in a company news release.

FDA approval was based on data from the pivotal phase 3 SATURN international study (n = 889) showing that use of erlotinib maintenance therapy (150 mg/day) immediately after first-line chemotherapy significantly increased overall survival by 23% relative to placebo (median, 12 vs 11 months; hazard ratio, 0.81; 19% reduction in risk for death; P = .0088).

Progression-free survival was improved by 41% (median, 2.8 months vs 2.6 months; hazard ratio, 0.71; 29% reduction in risk for cancer progression/death; P < .0001).

Adverse events most commonly reported in patients receiving erlotinib maintenance therapy included rash-like events (49%; grade 3, 6%) and diarrhea (20%; grade 3, 2%).

Erlotinib previously was approved for the treatment of NSCLC after failure of at least 1 prior chemotherapy regimen and in combination with gemcitabine for the first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

Other potential indications currently under investigation include the first-line treatment of patients with lung cancer with an activating epidermal growth factor receptor mutation, the adjuvant treatment of NSCLC, and the treatment of other tumor types such as ovarian cancer and hepatocellular carcinoma.