Five New FDA Approvals Bring Advances in Cancer and Pulmonary Hypertension Treatment – October 2025
Washington, D.C. - The food and Drug Management (FDA) authorized five significant expansions of treatment options in October 2025, impacting patients battling relapsed or refractory acute myeloid leukemia (AML) and pulmonary arterial hypertension (PAH). These approvals-including new indications and formulations-represent critical steps forward in addressing challenging conditions with limited therapeutic avenues. The decisions underscore the FDA’s commitment to accelerating access to innovative therapies and improving patient outcomes.
These recent approvals are particularly noteworthy given the increasing prevalence of both AML and PAH, and the often-limited effectiveness of existing treatments.The expanded indications offer renewed hope for patients who have exhausted standard care options, while the new formulations aim to improve treatment adherence and quality of life. Further research and post-market surveillance will be crucial to fully understand the long-term benefits and potential risks associated with these therapies.
Here’s a breakdown of the approvals from October 2025:
* Revumenib (AbbVie): On October 25, 2025, the FDA granted approval for revumenib for adult patients with relapsed or refractory AML whose tumors harbor an NPM1 mutation. This approval marks a significant advancement for this specific AML subtype, offering a targeted therapy option where few existed previously.
* Sotatercept (Johnson & Johnson): The FDA broadened the indication for sotatercept on October 27, 2025, to include patients with pulmonary arterial hypertension (PAH) who are World Health Organization (WHO) group 1 and have a six-minute walk distance of 380-500 meters.This expansion provides a new treatment pathway for a wider range of PAH patients.
* Elrexfio (Pfizer): On October 11, 2025, the FDA approved Elrexfio (elranatamab-bcmm) for adult patients with multiple myeloma who have received at least four prior lines of therapy.
* Talvey (Pfizer): the FDA approved Talvey (talquetamab-tgvs) on October 11, 2025, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
* Omisirge (Hope Pharmaceuticals): On October 2, 2025, the FDA approved Omisirge (omidubicel-onlv), the first cell-based therapy for hematopoietic stem cell transplantation. It is indicated for patients 18 years and older with blood or marrow cancers who are undergoing hematopoietic stem cell transplantation following myeloablative conditioning.
