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FDA monthly preview: Key October decisions to watch

Several FDA decisions across multiple specialties are expected this month.

  • By

  • Kathryn Wighton

  • September 25, 2026

  • 5 min

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Clinical Report: FDA Monthly Preview: Key October Decisions to Watch

Overview

The FDA is expected to make regulatory decisions in October 2026 regarding several therapies, including atezolizumab for colon cancer and ifinatamab deruxtecan for small cell lung cancer. Other applications include satralizumab for thyroid eye disease and bepirovirsen for chronic hepatitis B.

Background

The upcoming FDA decisions pertain to various therapeutic areas, including oncology, ophthalmology, gastroenterology, and rheumatology.

Data Highlights

TherapyIndicationPDUFA DateKey Findings
AtezolizumabColon CancerOctober 9, 202650% reduction in recurrence/mortality risk
Ifinatamab DeruxtecanSmall Cell Lung CancerOctober 10, 2026Supported by phase 2 trial results
SatralizumabThyroid Eye DiseaseOctober 15, 202653% proptosis response rate
BepirovirsenChronic Hepatitis BOctober 26, 2026Higher functional cure rates than standard care
Tildrakizumab-asmnPsoriatic ArthritisOctober 29, 2026Based on phase 3 trial results
INO-3107Recurrent Respiratory PapillomatosisOctober 30, 202672% decrease in surgeries

Key Findings

  • Atezolizumab plus FOLFOX6 chemotherapy reduced recurrence or mortality risk by 50% in colon cancer.
  • Ifinatamab deruxtecan is under review for small cell lung cancer, supported by phase 2 trial data.
  • Satralizumab showed a 53% proptosis response rate in thyroid eye disease compared to 23% with placebo.
  • Bepirovirsen demonstrated higher functional cure rates for chronic hepatitis B than standard care.
  • Tildrakizumab-asmn is being evaluated for active psoriatic arthritis based on phase 3 trial results.
  • INO-3107 treatment led to a 72% decrease in surgeries for recurrent respiratory papillomatosis.

Clinical Implications

These upcoming FDA decisions may lead to new treatment options for patients with various serious conditions. Healthcare professionals should stay informed about these developments to optimize patient management and treatment strategies.

Conclusion

The anticipated FDA decisions in October 2026 highlight significant advancements in therapeutic options across multiple disease areas. Continued monitoring of these developments is essential for clinical practice.

Related Resources & Content

  1. MDSpire News, FDA Monthly Preview: Key August Decisions to Watch
  2. MDSpire News, FDA Monthly Preview: Key September Decisions to Watch
  3. MDSpire News, FDA Monthly Preview: Key July Decisions to Watch
  4. FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
  5. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
  6. Systemic Therapy for Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update
  7. MDSpire News — FDA Monthly Preview: Key April Decisions to Watch
  8. FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma | FDA
  9. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up☆ - Annals of Oncology
  10. Systemic Therapy for Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update | Journal of Clinical Oncology
  11. WSOPRAS and ITEDS Consensus Statement on the Assessment and Management of Thyroid Eye Disease.
  12. Vuity - EyeWiki
  13. AASLD Announces New Practice Guideline on Treatment of Chronic Hepatitis B
  14. EULAR points to consider and consensus definitions for difficult-to-manage and treatment-refractory psoriatic arthritis - ScienceDirect
  15. Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP - PMC

Original Source(s)

FDA monthly preview: Key October decisions to watch

  • by Kathryn Wighton

  • September 25, 2026

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