FDA NewsDrug Pipeline

FDA grants orphan drug designation to entrectinib for colorectal cancer

The FDA has granted orphan drug designation to entrectinib for the treatment of several molecularly-defined subtypes of colorectal cancer, according to the drug’s manufacturer.

Entrectinib (Ignyta) is a selective tyrosine kinase inhibitor designed to treat patients with cancer who harbor activating alterations in TrkA, TrkB, TrkC, ROS1 or ALK.

“We are pleased to receive from the FDA this orphan drug designation for colorectal cancer, our third orphan designation in addition to neuroblastoma and non–small cell lung cancer,” Jonathan Lim, MD, chairman and CEO of Ignyta, said in a press release. “Entrectinib has the potential to address unmet needs of patients with rare cancers, and we will continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of these patients and to create value for our stockholders.”

Entrectinib has demonstrated in vivo antitumor activity against certain TrkA, ROS1 and ALK–driven mouse xenograft models of different human cancers.

Entrectinib currently is being investigated in two phase 1/phase 2 clinical trials — the STARTRK-1 trial and the ALKA-372-001 trial.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

The FDA has granted orphan drug designation to entrectinib for the treatment of several molecularly-defined subtypes of colorectal cancer, according to the drug’s manufacturer.

Entrectinib (Ignyta) is a selective tyrosine kinase inhibitor designed to treat patients with cancer who harbor activating alterations in TrkA, TrkB, TrkC, ROS1 or ALK.

“We are pleased to receive from the FDA this orphan drug designation for colorectal cancer, our third orphan designation in addition to neuroblastoma and non–small cell lung cancer,” Jonathan Lim, MD, chairman and CEO of Ignyta, said in a press release. “Entrectinib has the potential to address unmet needs of patients with rare cancers, and we will continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of these patients and to create value for our stockholders.”

Entrectinib has demonstrated in vivo antitumor activity against certain TrkA, ROS1 and ALK–driven mouse xenograft models of different human cancers.

Entrectinib currently is being investigated in two phase 1/phase 2 clinical trials — the STARTRK-1 trial and the ALKA-372-001 trial.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.