Eli Lilly said last week that it received a complete response letter from the US Food and Drug Administration declining its application to market Erbitux as a first-line treatment for non-small cell lung cancer.
This article was originally posted on Sept. 1.
Roche last week said that the European Commission has approved the use of Tarceva as a first-line monotherapy for non-small cell lung cancer in patients with EGFR activating mutations.
Continuing to expand the development program for its irreversible inhibitor of EGFR and HER2, afatinib, Boehringer Ingelheim Pharmaceuticals has launched two new Phase II studies — one investigating the drug as a treatment for inflammatory breast cancer and another for metastatic
Following a positive recommendation from the EMA committee, the European Commission is expected to issue a decision in September regarding marketing Tarceva as a first-line treatment for EGFR-mutation-positive NSCLC.
"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.
Although the decision to withdraw its accelerated approval NDA doesn't preclude the company from filing an entirely new NDA for Iressa in NSCLC patients with EGFR mutations, as it has done in several European countries, AstraZeneca has decided not to try to relaunch Iressa with a PGx strategy in the US.