As reported by OncLive®, October 2025:　FDA Grants Fast Track Designation to NBM-BMX for Metastatic Uveal Melanoma

TAIPEI and San Diego, USA – NovelWise Pharmaceutical Corporation  announced that its investigational agent NBM-BMX, a selective HDAC8 inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic uveal melanoma, a rare and aggressive eye cancer with limited therapeutic options.

According to OncLive®, the leading oncology news resource under MJH Life Sciences, this designation acknowledges the urgent need for more effective therapies in advanced uveal melanoma and enables NovelWise to work closely with the FDA to accelerate the development and review of NBM-BMX.

“The Fast Track designation underscores NBM-BMX’s potential to address a critical unmet medical need,” NovelWise stated. “We are committed to advancing this program efficiently and responsibly to bring a new treatment option to patients worldwide.”

NBM-BMX is the first HDAC8-selective inhibitor to advance into global clinical development for uveal melanoma. The compound has demonstrated promising preclinical antitumor activity and an acceptable safety and tolerability profile in early clinical evaluation. The ongoing multicenter clinical trial is currently being conducted in the United States.

The FDA Fast Track designation provides opportunities for more frequent interaction with the Agency and eligibility for Priority Review, aiming to expedite the potential approval process for therapies that address serious and life-threatening conditions.

Read the original OncLive® coverage:
https://www.onclive.com/view/fda-grants-fast-track-status-to-nbm-bmx-for-metastatic-uveal-melanoma