October 2, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Five-year-old startup Clovis Oncology is reportedly seeking approval for its lung cancer drug from regulators, hoping to beat huge rival AstraZeneca , who is also looking for approval for a drug aimed at the same disease.
The drugs that both companies have created target a form of non-small cell lung cancer that has resisted treatment in the past. They have each received breakthrough therapy designation from the U.S. Food and Drug Administration. As a result, the review of the drugs will be expedited.
Clovis’ Progression in Lung Cancer
In May, Clovis announced that the FDA had given itbreakthrough therapy designation for the company’s CO-1686 as monotherapy. CO-1686 is Clovis’ oral, targeted inhibitor of mutant forms of the epidermal growth factor receptor for the treatment of non-small cell lung cancer.
“We very much appreciate this designation by FDA, which recognizes the meaningful benefit CO-1686 may provide patients with T790M positive NSCLC,” said PatrickMahaffy, President and CEO of Clovis Oncology. “This designation is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application by mid-2015.”
AstraZeneca’s Lung Cancer Drug
Around the same time in May, AstraZeneca announced thestart of a Phase 3 program for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer. MEDI4736 is a human monoclonal antibody directed against the programmed cell death ligand1, PD-L1. A total of 702 patients were designated to participate in the Phase 3 study across more than 100 sites around the world.
“MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase 3 clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline,” said Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca. “Lung cancer is still the leading cancer killer; there is a clear need for more treatment options to provide patients with a better chance of beating the disease. We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment.”
Lung cancer was responsible for 1.5 million deaths in 2012, according to the World Health Organization.
