FDA Grants Fast Track Designation to IN10018 for Treatment of Platinum-resistant Ovarian Cancer

The designation highlights the need for new treatment options for patients with platinum-resistant ovarian cancer and the significant treatment potential of IN10018, according to a press release from InxMed, the manufacturer of the novel drug.

IN10018 (InxMed) has been granted Fast Track designation by the FDA for the treatment of platinum-resistant ovarian cancer. The designation highlights the need for new treatment options for patients with platinum-resistant ovarian cancer and the significant treatment potential of IN10018, according to a press release from InxMed, the manufacturer of the novel drug.

Currently, surgery and platinum-based chemotherapy are the main treatment regimens for ovarian malignant tumors. Although chemotherapy significantly impacts patients who are primarily treated, these patients end up developing platinum drug resistance, leading to rapid disease progression. As a result, there are limited treatment options and overall survival prognosis remains low at 1 year.

Preclinical and clinical data from InxMed showed IN10018’s efficacy when combined with standard chemotherapy to treat patients with platinum-resistant ovarian cancer, according to the press release.

"This is an important milestone for InxMed. IN10018 is one of our critical assets to fulfill our ‘Best-in-Disease Combination’ development strategy,” said Zaiqi Wang, MD, InxMed chairman and CEO, in a press release. “We will leverage the advantage of Fast Track status and work closely with US FDA to speed up further clinical development. InxMed will fully accelerate global clinical development of IN10018 to better meet the patient's needs."

REFERENCE

InxMed's IN10018 Receives U.S. FDA Fast Track Designation for the Treatment of Platinum-resistant Ovarian Cancer. PR Newswire. August 15, 2021. Accessed August 17, 2021. https://www.prnewswire.com/news-releases/inxmeds-in10018-receives-us-fda-fast-track-designation-for-the-treatment-of-platinum-resistant-ovarian-cancer-301355503.html