FDA News

FDA grants orphan drug designation to CRS-207 for mesothelioma

The FDA granted orphan drug designation to CRS-207 — a novel immuno-oncology product candidate — for the treatment of patients with malignant pleural mesothelioma, according to a press release from the drug’s manufacturer.

CRS-207 (Aduro Biotech) is intended for use in patients with malignant pleural mesothelioma who have not received prior therapy and who are not eligible for surgical resection.

Patient enrollment is ongoing for a single-arm, phase 1B clinical trial of CRS-207 in combination with standard-of-care chemotherapy.

Interim results of this study — presented at the International Mesothelioma Interest Group Conference in October — demonstrated a 94% disease control rate among the 16 evaluable patients who received chemotherapy plus CRS-207. Seventy-five percent (n = 12) of patients had confirmed partial responses and 19% (n = 3) of patients experienced stable disease.

Estimated PFS was 7.5 months at the time of the presentation. One patient who has been enrolled on the study for more than 19 months is currently receiving maintenance therapy with CRS-207 alone.

Based on the interim results, Aduro opened an expansion cohort of up to a total of 40 patients and expects to finish enrollment this year, with top-line results to be presented in 2016, according to the press release.

“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” Dirk Brockstedt, PhD, senior vice president of research and development at Aduro Biotech, said in the release. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing phase 1b study later this year.”

CRS-207 previously received FDA orphan drug designation in combination with GVAX Pancreas for the treatment of pancreatic cancer.

The FDA’s 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 granted orphan drug designation to CRS-207 — a novel immuno-oncology product candidate — for the treatment of patients with malignant pleural mesothelioma, according to a press release from the drug’s manufacturer.

CRS-207 (Aduro Biotech) is intended for use in patients with malignant pleural mesothelioma who have not received prior therapy and who are not eligible for surgical resection.

Patient enrollment is ongoing for a single-arm, phase 1B clinical trial of CRS-207 in combination with standard-of-care chemotherapy.

Interim results of this study — presented at the International Mesothelioma Interest Group Conference in October — demonstrated a 94% disease control rate among the 16 evaluable patients who received chemotherapy plus CRS-207. Seventy-five percent (n = 12) of patients had confirmed partial responses and 19% (n = 3) of patients experienced stable disease.

Estimated PFS was 7.5 months at the time of the presentation. One patient who has been enrolled on the study for more than 19 months is currently receiving maintenance therapy with CRS-207 alone.

Based on the interim results, Aduro opened an expansion cohort of up to a total of 40 patients and expects to finish enrollment this year, with top-line results to be presented in 2016, according to the press release.

“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” Dirk Brockstedt, PhD, senior vice president of research and development at Aduro Biotech, said in the release. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing phase 1b study later this year.”

CRS-207 previously received FDA orphan drug designation in combination with GVAX Pancreas for the treatment of pancreatic cancer.

The FDA’s 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.