Selinexor once weekly can be safely combined with pomalidomide and dexamethasone in heavily pretreated patients with multiple myeloma (MM), according to the results of a study presented at the 2021 American Society of Clinical Oncology Annual Meeting. In the multi-arm phase 1b/2 STOMP study (ClinicalTrials.gov Identifier: NCT02343042), investigators evaluated selinexor at...
treatment News
PALO ALTO, Calif. — Orbus Therapeutics, Inc., a private pharmaceutical company, today announced the publication of the Phase 3 STELLAR clinical study results demonstrating that the combination of eflornithine and lomustine achieved clinically meaningful improvements in OS and PFS compared to lomustine alone in patients with recurrent IDH mutant, grade...
PALO ALTO, Calif. — Orbus Therapeutics, Inc., a private pharmaceutical company, today announced the presentation of the Phase 3 STELLAR clinical study results showing clinically meaningful benefits in patients with grade 3 astrocytoma—an aggressive brain tumor with a median survival of only two to five years post-diagnosis. The results will...
MENLO PARK, Calif. — Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T, its lead investigational allogeneic T-cell immunotherapy,...
BOSTON and LONDON – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced data published in the New England Journal of Medicine (NEJM) evaluating the safety and efficacy of OTL-203 for the treatment of the Hurler subtype of Mucopolysaccharidosis type I (MPS-IH). OTL-203 is an investigational autologous hematopoietic stem cell...
TOKYO, LONDON and BOSTON — Orchard Therapeutics, a Kyowa Kirin company, today announced the last patient has been treated in a registrational trial evaluating the efficacy and safety of OTL-203, an investigational hematopoietic stem cell (HSC) gene therapy, in patients with the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The...
TOKYO, LONDON and BOSTON — Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, for the treatment of children...
BOSTON and LONDON — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OTL-203, an investigational hematopoietic stem cell gene (HSC) therapy being developed for the potential treatment of the Hurler subtype of mucopolysaccharidosis type I...
BOSTON and LONDON — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, announced various business accomplishments along with its financial results for the quarter ended March 31, 2023. “Following multiple productive interactions this year with the FDA on our clinical and CMC packages, I am delighted to announce the...
Boston and London — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, announced that the company will make a virtual presentation at the Guggenheim Genomic Medicines and Rare Disease Day on Tuesday, April 4, 2023 at 1:35pm ET. A live webcast of the presentation will be available under “News...