Fast-Tracking the $537B Cancer Cure: How Accelerated Approvals Reshaping Oncology in 2026
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Jan. 12, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The oncology landscape is entering a high-velocity regulatory phase as genomics in cancer care expands toward a projected $69.16 billion by 2032[1]. This massive growth is driven by the systematic integration of genotype-directed treatment pathways into standard medical practice. The precision medicine market is now on a trajectory to expand from $138.67 billion in 2026 to over $537.17 billion by 2035[2]. This strategic pivot toward registration-ready precision assets fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ:ONCY), CG Oncology (NASDAQ:CGON), Zentalis Pharmaceuticals (NASDAQ:ZNTL), ArriVent BioPharma (NASDAQ:AVBP), and PDS Biotechnology (NASDAQ:PDSB).
The financial momentum behind expedited development pathways is reaching a fever pitch: the orphan drug market is projected to surge from $216.66 billion in 2025 to $687.47 billion by 2035[3]. Current FDA accelerated approval frameworks have already demonstrated meaningful population health gains across 65% of solid tumor indications studied[4]. This validates a new generation of registration-directed study designs that prioritize objective response rates as critical catalysts for major capital allocation in the fight against rare and resistant cancers.
Oncolytics Biotech Inc. (NASDAQ:ONCY) is advancing pelareorep, an investigational immunotherapy, toward potential accelerated approval in anal cancer after reporting third-line data that nearly tripled historical response rates in a setting with no FDA-approved treatment options.
The company announced updated clinical data from GOBLET Cohort 4 showing pelareorep combined with atezolizumab achieved a 29% objective response rate in patients with third-line metastatic squamous cell anal carcinoma (SCAC). These responses included two complete responses among 14 evaluable patients. Notably, the median duration of response was approximately 17 months (67 weeks). Historical third-line SCAC studies typically show objective response rates of approximately 10% or less, and when responses do occur, duration of response is generally limited.
The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses.
This depth and durability of responses in heavily pretreated patients address a critical unmet need. There are currently no FDA-approved therapies for patients with third-line anal cancer, making pelareorep's activity particularly significant for a patient population with virtually no options outside of chemotherapy.
Based on these results and after initial encouraging feedback from the FDA, Oncolytics plans to advance pelareorep into a registration-directed clinical study in second-line and later SCAC. Oncolytics is planning a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.
If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies.
"As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients' lives who have no options."
The company's broader gastrointestinal oncology strategy received validation through expansion of its Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease.
Leading the charge is CEO Jared Kelly and Chief Business Officer Andrew Aromando, who were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson.
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:
CG Oncology (NASDAQ:CGON) announced an expedited timeline for the topline data readout now expected in the first half of 2026 for its Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines, including HG Ta solitary lesions < 3cm, with enrollment completed early across over 90 sites.
"We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment," said Arthur Kuan, Chairman and CEO of CG Oncology. "The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC."
The expedited timeline represents nearly one year of advancement from the original schedule. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in more than 400 patients with NMIBC across multiple clinical trials, including the pivotal BOND-003 trial.
Zentalis Pharmaceuticals (NASDAQ:ZNTL) provided a corporate update highlighting key milestones and expected momentum in the azenosertib development program for 2026, including completion of enrollment in DENALI Part 2a with dose confirmation expected in the first half of 2026. DENALI Part 2 trial topline readout is expected by year end 2026 with potential to support accelerated approval, while initiation of the ASPENOVA Phase 3 randomized confirmatory trial is planned in the first half of 2026.
"2026 represents a pivotal year for Zentalis as we advance azenosertib toward potential approval in Cyclin E1-positive platinum-resistant ovarian cancer and continue to assess its role in additional indications," said Julie Eastland, Chief Executive Officer of Zentalis. "With our strong financial foundation providing an estimated runway into late 2027, we remain focused on executing our strategy to bring this potentially first-in-class, non-chemo, oral therapy to the approximately 50% of PROC patients who are Cyclin E1-positive—a population with significant unmet needs."
Strong data across three trials established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer. The Company maintained a strong cash position with $280.7 million in cash, cash equivalents and marketable securities as of September 30, 2025.
ArriVent BioPharma (NASDAQ:AVBP) announced the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC), with firmonertinib having the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy. The ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals with global ex-China annual incidence of NSCLC patients with EGFR PACC mutations estimated at approximately 42,000 patients.
"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, Ph.D., Chairman and Chief Executive Officer of ArriVent. "Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. We believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum."
The randomized Phase 3 study evaluates firmonertinib 240 mg once daily versus the investigator's choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. Firmonertinib was granted FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion mutations.
PDS Biotechnology (NASDAQ:PDSB) announced FDA alignment on the use of progression-free survival as the primary endpoint and submitted an amended protocol for Phase 3 VERSATILE-003 trial following a constructive Type C meeting held with the FDA in December 2025. The submission follows positive final results from the Company's VERSATILE-002 trial, which showed promising median overall survival and durable PFS, with the proposed amendment changing the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power.
The amendment retains median overall survival and safety as requirements for full FDA approval and is supported by dialogue with the agency, providing a pathway to potentially accelerate regulatory submission. PDS Biotech specializes in developing novel immunotherapies to transform cancer care, with PDS0101 being developed in combination with checkpoint inhibitors.
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SOURCES CITED:
1. https://www.globenewswire.com/news-release/2026/01/05/3212639/0/en/Genomics-in-Cancer-Care-Market-Size-to-Hit-USD-69-16-Billion-by-2032-Growing-at-a-CAGR-of-16-04-SNS-Insider.html
2. https://www.precedenceresearch.com/precision-medicine-market
3. https://www.towardshealthcare.com/insights/orphan-drug-market-sizing
4. https://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/
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