$207B Market Shift: The Race for Fast Track Approval in Oncology
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Feb. 5, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The FDA isn't just approving drugs; they are completely reshaping the landscape. In 2025 alone, the agency issued over 50 oncology approvals[1], but the real story is the aggressive pivot toward targeted therapies for high-unmet-need solid tumors. That momentum has accelerated in 2026 with a sudden flurry of expedited designations[2] for RAS inhibitors and rare malignancies. This regulatory velocity creates a clear validation framework, positioning Oncolytics Biotech Inc. (NASDAQ:ONCY), Relay Therapeutics (NASDAQ:RLAY), MAIA Biotechnology (NYSE-A: MAIA), Zai Lab (NASDAQ:ZLAB), and Arrivent BioPharma (NASDAQ:AVBP) directly at the convergence of urgent unmet medical need and commercial opportunity.
This is projected to be a $326.82 billion market opportunity by 2031[3], fueled by a robust expansion in antibody-drug conjugates and biomarker-driven regimens. But in biotech, time is the ultimate currency. Data confirms that Breakthrough Therapy Designation can slash late-stage development time by 30%[4]. For companies demonstrating clinical efficacy in difficult-to-treat populations, these expedited pathways are no longer just a bonus: they are the primary value drivers for scalable growth.
Oncolytics Biotech Inc. (NASDAQ:ONCY) just received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.
The designation is based on clinical data showing pelareorep combined with standard chemotherapy achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.
This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually.
"Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.
The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.
Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.
Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Relay Therapeutics (NASDAQ:RLAY) has announced FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following progression on CDK4/6 inhibitor treatment. The designation was supported by clinical data from the ReDiscover trial with 600mg BID fasted and 400mg BID fed doses showing comparable exposures across all PIK3CA mutations.
"This Breakthrough Therapy designation underscores the FDA's recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date," said Don Bergstrom, President of R&D at Relay Therapeutics.
Initial Phase 1/2 data of zovegalisib plus fulvestrant at the 400mg BID fed Phase 3 dose in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16. Relay Therapeutics developed zovegalisib as the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor designed to overcome limitations of traditional orthosteric inhibitors.
MAIA Biotechnology (NYSE-A: MAIA) has advanced its ateganosine program as the first and only telomere-targeting anticancer agent in clinical development, securing FDA Fast Track designation for the treatment of non-small cell lung cancer (NSCLC). The company initiated a pivotal Phase 3 trial in third-line NSCLC and expanded its Phase 2 trial with a $2.3 million NIH grant while establishing agreements with Roche and BeOne Medicines for checkpoint inhibitor combinations.
"MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, CEO of MAIA Biotechnology. "Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials."
The company targets potential commercial approval within 18 to 24 months, with 2026 milestones including interim Phase 3 efficacy data and Phase 2 trial conclusion. MAIA Biotechnology raised approximately $17.6 million in 2025 with board participation in nearly all transactions.
Zai Lab (NASDAQ:ZLAB) announced that China's National Medical Products Administration has approved the supplemental New Drug Application for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval marks the second indication in China for the next-generation tyrosine kinase inhibitor, which demonstrated robust and durable efficacy and manageable safety in the pivotal Phase 1/2 TRIDENT-1 study.
"We are pleased with the NMPA's approval of AUGTYRO for patients with NTRK-positive solid tumors," said Rafael Amado, President, Head of Global Research and Development at Zai Lab. "This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population."
The approval represents the first in China to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors. Zai Lab has an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China, following their acquisition of Turning Point Therapeutics.
Arrivent BioPharma (NASDAQ:AVBP) announced first patient dosing in the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant non-small cell lung cancer. The oral, once-daily, brain-penetrant therapy demonstrated 16-month median progression-free survival and 68% confirmed objective response rate in the FURTHER trial, supporting selection of the 240 mg dose for pivotal development.
"Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, CEO of Arrivent BioPharma. "With a well-characterized safety profile and broad clinical systemic and central nervous system activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations."
The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. Arrivent BioPharma estimates the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients.
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SOURCES:
- https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/
- https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicine
- https://www.mordorintelligence.com/industry-reports/solid-tumor-therapeutics-market
- https://pmc.ncbi.nlm.nih.gov/articles/PMC12758617/
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