FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients Announced
“FDA authorization for the EAP highlights its awareness of the safety and efficacy profile of Bria-IMT™ and patients’ need to access such a novel treatment. While we are conducting our pivotal Phase 3 trial of Bria-IMT™ regimen with an immune checkpoint inhibitor, Bria-IMT™ may provide a treatment option for cancer patients in need,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite numerous approved drugs, breast cancer remains the second leading cause of cancer death in American women. With our novel immunotherapy, we expect to bring hope to patients and families suffering from this deadly disease.”
Share:
More News
“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program,” said
“We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas said, “The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are
“U.S. FDA has accepted for review the resubmission of the BLA for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last
