Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive Orphan Drug Designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall.”
Share:
More News
“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,
“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are