Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA has calculated the regulatory review period for the biologic drug VYLOY (zolbetuximab-clzb) as 2,471 days total. This consists of a 1,945-day testing phase that began on January 14, 2018, when the IND became effective, and a 526-day approval phase that ran from the BLA submission on May 12, 2023, until FDA approval on October 18, 2024. The product is approved for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or GEJ adenocarcinoma in combination with chemotherapy. This determination sets the maximum possible patent term extension for 11 listed U.S. patents owned by Astellas and partners. Applicants are seeking between 66 and 1,499 days of extension. Comments challenging the dates must be submitted by June 2, 2026, and due-diligence petitions by September 30, 2026.
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Key Changes
- Total regulatory review period determined as 2,471 days
- Testing phase: 1,945 days from January 14, 2018 (IND effective date)
- Approval phase: 526 days from May 12, 2023 (BLA submission) to October 18, 2024 (FDA approval)
+ 3 more changes with Pro
Obligations
What this law requires
Submit comments challenging the published regulatory review period dates for VYLOY by 11:59 p.m. Eastern Time on June 2, 2026, via https://www.regulations.gov or by mail/hand delivery to FDA Dockets Management Staff
Include all applicable Docket Nos. (FDA-2025-E-0845 through FDA-2025-E-0872) in any submitted comments or petitions regarding VYLOY patent extension determination
Submit petitions regarding whether the patent extension applicant acted with due diligence during the regulatory review period by September 30, 2026
For confidential submissions, provide two copies—one with confidential information marked as 'THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION' and one with confidential information redacted—to FDA Dockets Management Staff
Ensure submitted comments do not include confidential information, medical information, Social Security numbers, or confidential business information that should not be made publicly available on https://www.regulations.gov