U.S. FDA Accepts For Priority Review The sBLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer

“Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “People with pre-treated HR+/HER2- metastatic breast cancer who have progressed on endocrine-based therapies and chemotherapy have limited treatment options, and we look forward to working with the FDA to potentially make Trodelvy available to patients who need it most.”
Share:
More News
“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not
Chris Ehrlich, CERo Therapeutics CEO added, “CBCI is a world-renowned cancer center, and we believe their participation in our AML trial is continued validation of the scientific work performed to date with CER-1236. We look forward to announcing enrollment and initial dosing in the near term for this trial and
“Treating the first patient in the GUARDIAN-101 trial marks a pivotal milestone in Clasp’s mission to transform patient outcomes through precision immunotherapy,” said Dr. Lauren Harshman, M.D., SVP of Clinical Development at Clasp Therapeutics. “Advancing CLSP-1025 into the clinic is an important step in validating the potential of our pHLAre
“AP402 targets p95HER2, a truncated form of HER2 present in 30-40% of HER2-positive cancers, which is associated with exceptionally poor prognosis, and not addressable by conventional anti-HER2 therapies,” said Dr. Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. “AP402 represents the only T-cell engager in human trials