Drugmakers are accelerating cancer development in 2026 as FDA fast‑track pathways, rising precision medicine investment, and promising clinical data reshape oncology drug approvals and expand treatment options for patients with limited therapies.
Accelerated Approvals Drive Oncology Investment in 2026
Regulators and drug developers are increasingly relying on accelerated pathways as precision medicine reshapes oncology drug approvals in 2026, according to industry data released on Monday.
The global precision medicine market is projected to grow from $138.67 billion in 2026 to more than $537 billion by 2035, driven by genotype-directed cancer treatments entering routine practice. The genomics segment alone is forecast to reach $69.16 billion by 2032.
Oncology drug approvals have demonstrated population‑level benefits across about 65% of studied solid tumor indications, according to the release. These approvals often rely on objective response rates and durability of response, particularly in rare or treatment‑resistant cancers with few alternatives.
The orphan drug market is also expanding rapidly, with projections rising from $216.66 billion in 2025 to nearly $687.5 billion by 2035, underscoring investor interest in therapies targeting unmet needs.
Oncolytics Reports Strong Anal Cancer Data
Oncolytics Biotech Inc. reported clinical results that could position its investigational immunotherapy Pelareorep for accelerated approval in anal cancer, a disease with no FDA-approved third-line treatments.
Updated data from the GOBLET Cohort 4 study showed a 29% objective response rate when Pelareorep was combined with atezolizumab in third‑line metastatic squamous cell anal carcinoma. Among fourteen evaluable patients, there were two complete responses and a median duration of response of about seventeen months, highlighting results that could support future oncology drug approvals.
Historical studies in this setting typically show response rates of about ten percent or less, with shorter durability, according to the company.
Second-line data also showed a 30% response rate, compared with a 13.8% benchmark for the only FDA-approved immunotherapy in that setting.
“When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points directly to a registration study,” said Jared Kelly, chief executive officer of Oncolytics. He said the results suggest the therapy could make “an immediate impact on patients’ lives who have no options.”
Oncolytics plans a Type C meeting with the FDA in the first quarter of 2026 to discuss a registration-directed study in second-line and later anal cancer.
Multiple Drugmakers Advance Registration-Ready Trials
Other oncology companies also reported progress tied to expedited regulatory strategies.
CG Oncology said it expects topline Phase three data in the first half of 2026 for its PIVOT‑006 trial in intermediate‑risk non‑muscle invasive bladder cancer, nearly one year earlier than planned due to rapid enrollment across more than ninety sites, marking a key step toward potential oncology drug approvals.
Arthur Kuan, chairman and chief executive officer of CG Oncology, noted that the IR population in the U.S. is estimated to exceed fifty thousand patients, underscoring the significant need for future oncology drug approvals.
Zentalis Pharmaceuticals said 2026 will be a pivotal year for advancing azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer, with enrollment completion and Phase three trial initiation planned. The company reported $280.7 million in cash as of Sept. 30, 2025.
ArriVent BioPharma announced dosing of the first patient in its global Phase three ALPACCA trial evaluating firmonertinib for a subset of non-small cell lung cancer patients with limited options.
PDS Biotechnology said it received FDA alignment on progression-free survival as the primary endpoint for its Phase three VERSATILE-003 trial, potentially enabling earlier regulatory submission.
Together, the developments reflect how accelerated approvals and precision medicine are reshaping oncology pipelines and regulatory timelines in 2026.
