Regulatory Milestone: Optune Lua Receives FDA Approval for Metastatic NSCLC

On October 15, 2024, the US Food and Drug Administration (FDA) granted approval to Optune Lua, a novel tumor treating fields (TTF) device, for use in adults with metastatic non–small cell lung cancer whose disease has progressed following platinum-based chemotherapy. This marks the first FDA approval for TTF therapy in metastatic NSCLC and highlights the regulator’s continued focus on broadening treatment modalities in oncology.

With this approval, Optune Lua joins a growing list of FDA-cleared technologies for use in difficult-to-treat cancers. The therapy offers a new mechanism of action that complements existing standards of care and underscores ongoing progress in combination and device-based oncology approaches.

Funding Rounds: Private Investment Heats Up for Oncology and Metabolic Startups

October proved a banner month for private biotech funding rounds, with oncology-related startups attracting 19% of all investment capital raised—totaling more than $590 million across 10 disclosed rounds. North American companies led the way, while notable Series A deals tipped toward innovative programs in solid tumor therapies and immuno-oncology. Elsewhere, a single startup in the obesity segment closed a record-breaking $400 million Series A, further illustrating investor appetite for metabolic disease innovation.

Among the standouts, ArsenalBio announced a $325 million raise to accelerate its pipeline of T cell therapies for solid tumors, signifying continued confidence in synthetic biology and engineered cell therapy platforms.

Clinical Innovation: Fast Track and Orphan Designations Sustain Pipeline Momentum

In the same week, the FDA granted rare pediatric disease designation to galinpepimut-S for pediatric acute myeloid leukemia and fast track designation to LP-184 for glioblastoma. These designations are helping biotech innovators expedite development of urgently needed therapies—critical for patient populations with limited treatment options.

Clinical Trials and Research Updates

A separate announcement revealed that a phase 3 trial of 64Cu-SAR-bisPSMA, a next-generation diagnostic agent for prostate cancer recurrence, is set to launch, while several gene therapy and targeted oncology programs advanced through first-in-human studies. These developments underscore the sector’s resilience and ongoing drive for breakthroughs despite broader economic headwinds.