FDA Grants Fast Track Designation to Oncoprex Combination for NSCLC

Oncoprex in combination with Tagrisso (osimertinib) received fast track designation from the Food and Drug Administration (FDA) to treat patients with non-small cell lung cancer (NSCLC) with EFGR mutations that progressed after treatment with Tagrisso alone, according to Genprex, Inc., the immunogene therapy’s manufacturer.

"Genprex is excited to receive this important FDA designation," Rodney Varner, chairman and chief executive officer of Genprex, said in a press release. "In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer.”

Fast track designation is granted if the agency has determined that the drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease, with a goal of expediting drugs for these serious conditions. To received fast track designation, drugs must show an advantage over other available therapies. For example, the drug could be more efficacious in treating a particular patient population, or it could significantly reduce the side effects that patients are experiencing from treatment — ultimately improving diagnosis and outcomes.

With a fast track designation, Oncoprex is eligible for accelerated approval or rolling review of its biologics license application, and is also eligible for priority review if supported by clinical data at the time of the biologics license application submission.

“We hope that fast track designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment,” Varner added.

Genprex plans to initiate a phase 1/2 trial to evaluate the agent in combination with Tagrisso, as well as a phase 1 trial to investigate Oncoprex plus a checkpoint inhibitor.

“Lung cancer is the world’s leading cause of cancer death, taking more lives each year than colon, breast and prostate cancers combined,” according to the release. “Each year, there are more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, there are more than 228,000 new cases of lung cancer and more than 142,000 deaths from lung cancer each year. NSCLC represents 84% of all lung cancers, and the five-year relative survival rate for metastatic lung cancer is less than 5%.”