> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Cites Pinnacle Biologics for Misleading Photofrin Promo Videos
- URL: https://www.fdaweb.com/fda-cites-pinnacle-biologics-for-misleading-photofrin-promo-videos/
- Published: 2026-06-25T12:00:00.000Z
- Updated: 2026-09-14T13:41:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161372

FDA has issued an untitled letter to Pinnacle Biologics, alleging that promotional videos for the company's cancer therapy Photofrin (porfimer sodium) contain false and misleading claims that misbrand the product under the Federal Food, Drug, and Cosmetic Act.

The CDER Office of Prescription Drug Promotion (OPDP) [letter](https://www.fda.gov/media/193307/download?attachment&ref=fdaweb.com) focuses on two mechanism-of-action videos promoting Photofrin for esophageal cancer and endobronchial non-small-cell lung cancer (NSCLC). FDA said the videos omit important information about the drug's approved indications, minimize serious safety risks, and make unsupported efficacy and immunologic benefit claims.

According to the agency, the videos fail to adequately communicate Photofrin's full FDA-approved indications, presenting only broad disease categories while omitting important patient population restrictions and limitations included in the prescribing information. While the full indications appear at the end of the videos, FDA said they are displayed briefly in small font alongside risk information, making them difficult for healthcare professionals to read and understand.

FDA also criticized the videos for failing to adequately disclose significant safety information. The agency said the promotional materials omit key contraindications, including the drug's contraindication in patients with porphyria and in patients whose tumors have eroded into major blood vessels.

The agency further cited the omission of serious warnings and precautions, including risks of gastrointestinal and esophageal perforation, fatal pulmonary hemorrhage, prolonged photosensitivity, airway obstruction and respiratory distress, and embryo-fetal toxicity.

OPDP said the presentation of risk information lacked balance, noting that benefits were highlighted through large text and animated graphics while safety information appeared only briefly as static text near the end of the videos.

The agency also took issue with specific claims made in the NSCLC video. FDA said a statement suggesting that debridement "may be performed" following photodynamic therapy incorrectly implied the procedure was optional, despite prescribing information describing debridement bronchoscopy as a mandatory component of treatment to reduce airway obstruction risk.

Additionally, FDA challenged claims that photodynamic therapy with Photofrin is "proven" to boost anti-tumor immunity and improve tumor cell immunogenicity. According to the agency, the cited scientific literature discussed immune responses observed in animal models of photodynamic therapy generally and did not provide evidence supporting such claims specifically for Photofrin.

The agency requested that Pinnacle immediately cease dissemination of the promotional materials and submit a written response within 15 working days detailing corrective actions, identifying other promotional pieces containing similar claims, and outlining plans to discontinue or revise those materials.

Photofrin is a photodynamic therapy agent approved for certain patients with esophageal cancer, high-grade dysplasia in Barrett's esophagus, and endobronchial non-small-cell lung cancer.