FDA News

FDA fast tracks necuparanib for metastatic pancreatic cancer

The FDA granted fast track designation to the investigation of necuparanib for treatment of patients with metastatic pancreatic cancer, according to a press release from the manufacturer.

Necuparanib (formerly M402, Momenta Pharmaceuticals) is a novel drug candidate for first-line treatment of metastatic pancreatic cancer in combination with paclitaxel (Abraxane, Celgene) and gemcitabine (Gemzar, Eli Lilly), the release said. It is engineered from unfractioned heparin to reduce anticoagulant activity while preserving antitumor properties in order to overcome the limitations of current heparins.

“Receipt of fast track designation from the FDA further supports our belief in the potential of necuparanib to enhance overall survival rates in patients with metastatic pancreatic cancer, a disease for which there are very limited treatment options,” Jim Roach, MD, Momenta’s chief medical officer, said in the release. “We look forward to taking full advantage of the opportunities that fast track designation allows in order to maximize the possibility of an accelerated path to approval.”

This fast track designation follows the successful completion of the part A dose escalation component of the phase 1/2 clinical trial in October 2014. Necuparanib received orphan drug designation in June 2014, and the phase 2 proof-of-concept part of the trial, which aims to assess the antitumor activity of necuparanib in combination with paclitaxel plus gemcitabine compared with paclitaxel plus gemcitabine alone, is in progress. Results are expected by the first half of 2017, according to the release.

The FDA granted fast track designation to the investigation of necuparanib for treatment of patients with metastatic pancreatic cancer, according to a press release from the manufacturer.

Necuparanib (formerly M402, Momenta Pharmaceuticals) is a novel drug candidate for first-line treatment of metastatic pancreatic cancer in combination with paclitaxel (Abraxane, Celgene) and gemcitabine (Gemzar, Eli Lilly), the release said. It is engineered from unfractioned heparin to reduce anticoagulant activity while preserving antitumor properties in order to overcome the limitations of current heparins.

“Receipt of fast track designation from the FDA further supports our belief in the potential of necuparanib to enhance overall survival rates in patients with metastatic pancreatic cancer, a disease for which there are very limited treatment options,” Jim Roach, MD, Momenta’s chief medical officer, said in the release. “We look forward to taking full advantage of the opportunities that fast track designation allows in order to maximize the possibility of an accelerated path to approval.”

This fast track designation follows the successful completion of the part A dose escalation component of the phase 1/2 clinical trial in October 2014. Necuparanib received orphan drug designation in June 2014, and the phase 2 proof-of-concept part of the trial, which aims to assess the antitumor activity of necuparanib in combination with paclitaxel plus gemcitabine compared with paclitaxel plus gemcitabine alone, is in progress. Results are expected by the first half of 2017, according to the release.