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News  ›  Benzinga

Fast-Tracking the $537B Cancer Cure: How Accelerated Approvals Reshaping Oncology in 2026

Benzinga Logo Benzinga • •By Prnewswire
Fast-Tracking the $537B Cancer Cure: How Accelerated Approvals Reshaping Oncology in 2026

The oncology landscape is experiencing rapid regulatory advancement as precision medicine and genomics expand significantly. Multiple biotech companies are advancing cancer therapies toward accelerated FDA approvals in 2026, with the precision medicine market projected to grow from $138.67 billion in 2026 to $537.17 billion by 2035. Key developments include Oncolytics' pelareorep showing strong response rates in anal cancer, CG Oncology's Phase 3 trial ahead of schedule, Zentalis advancing azenosertib in ovarian cancer, ArriVent initiating a pivotal Phase 3 study for firmonertinib, and PDS Biotechnology gaining FDA alignment on trial endpoints.

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Pelareorep demonstrated strong clinical efficacy with 29% objective response rate in third-line anal cancer (vs. historical 10% or less) and 30% in second-line setting. Planning registration-directed study with FDA Type C meeting in Q1 2026, positioning for potential accelerated approval in an unmet medical need indication.

Keywords
#accelerated approval #oncology #precision medicine #immunotherapy #cancer treatment #FDA #clinical trials #biotech #drug development

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