Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
“The FDA Orphan Drug Designation for avutometinib alone or in combination with defactinib in low-grade serous ovarian cancer is an important step in recognizing this rare cancer as a distinct disease that currently has no FDA-approved treatments,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “We are rapidly advancing the development program for avutometinib and defactinib in low-grade serous ovarian cancer with our ongoing Phase 3 clinical trial to deliver this new combination treatment to patients as quickly as possible. We remain on track to begin submission of an NDA to the FDA for Accelerated Approval of this combination in the first half of 2024 and preparing for a potential launch in 2025.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data