Talk:Infigratinib

COI edit request: replace press-release and publication; correct regulatory history

Disclosure: I work for BridgeBio Pharma, the developer of infigratinib, and have a conflict of interest. Per WP:PAID and WP:COI I am not editing the article directly and am requesting review of the following changes. My paid-contribution disclosure is on my user page.

The requests below aim to (a) replace a company press release with the peer-reviewed Phase 3 publication per WP:MEDRS, (b) remove an unsupported cross-trial superlative, (c) complete the regulatory history, including the withdrawal of the prior oncology approval, and (d) fix a typo.

Request 1 — Replace the Phase 3 paragraph (peer-reviewed source now available)

The current Phase 3 sentence is sourced to a company press release plus two papers about other drugs (see Request 4). The PROPEL 3 results were published in the New England Journal of Medicine in June 2026 and should be the source.

Current text:

Recent Phase 3 clinical trial results for infigratinib demonstrated an improvement in annualized growth velocity of +2.1 cm/yr compared to placebo, the largest reported in any Phase 3 trial for achondroplasia.[9][10][11] Infigratinib also demonstrated a statistically significant change in upper-to-lower body proportionality in children 3-8 years of age. There were no treatment-related serious adverse events, and the drug was well-tolerated.[10]

Proposed text:

In the Phase 3 PROPEL 3 trial, 114 children aged 3 to under 18 years with achondroplasia were randomised to once-daily oral infigratinib or placebo across 27 sites. The trial met its primary endpoint of change from baseline in annualized height velocity at Week 52, with a least-squares mean treatment difference of 1.74 cm/year (p<0.0001); the observed mean difference was 2.10 cm/year. A nominally statistically significant improvement in upper-to-lower body segment ratio was observed in a pre-specified subgroup of children aged 3 to under 8 years. No treatment-related serious adverse events were reported.

Rationale: Replaces press-release sourcing with the peer-reviewed publication (WP:MEDRS); removes the cross-trial superlative "the largest reported in any Phase 3 trial for achondroplasia," which is not supported by a comparative source; distinguishes the least-squares mean from the observed difference; corrects the age description (proportionality was a pre-specified subgroup aged 3 to under 8, within an enrollment range of 3 to under 18); removes "well-tolerated" as editorializing.

Request 2 — Update the regulatory designations sentence

Current text:

Infigratinib received Breakthrough Therapy Designation from the FDA, the first therapeutic option in development for achondroplasia to receive this designation.[13] Infigratinib was designated an orphan drug by the FDA[14] and the European Medicines Agency in 2021.[15]

Proposed text:

Infigratinib has received Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for achondroplasia, and orphan designation from the European Medicines Agency in 2021. The Breakthrough Therapy Designation, granted in September 2024, was the first for an investigational therapy in achondroplasia.

Rationale: Adds two FDA designations (Fast Track, Rare Pediatric Disease) missing from the article and dates the Breakthrough Therapy Designation. I recognize the two added designations are currently sourced to a company announcement; if reviewers prefer, the FDA's databases or independent coverage can substitute, or the additions can be limited to what independent sources support.

Request 3 — Complete the prior-approval history (withdrawal is currently omitted)

Current text:

It was previously approved for medical use for bile duct cancer under the FDA's accelerated approval program in May 2021 at a significantly higher dose than that used for achondroplasia or hypochondroplasia.[16][17]

Proposed text:

It was previously marketed as Truseltiq for metastatic cholangiocarcinoma following FDA accelerated approval in May 2021, at a substantially higher dose than that studied in achondroplasia or hypochondroplasia. The manufacturer withdrew the product from the United States market in October 2022, and the FDA formally withdrew the approval in May 2024.

Rationale: The article currently says "previously approved" without stating that the approval ended. Adding the market withdrawal (October 2022) and the FDA's formal withdrawal of approval (May 2024, Federal Register) makes the history complete and accurate. Note this request adds unfavorable information about the company's product; it is proposed for completeness.

Request 4 — Flag possibly misattached references (no text change proposed)

References [9] and [11] on the Phase 3 sentence are Savarirayan et al. JAMA Pediatrics 2026 (navepegritide, the APPROACH trial) and Savarirayan et al. Lancet 2020 (vosoritide). Both concern other drugs and do not directly support the infigratinib Phase 3 sentence they are attached to. Because of my COI I am not proposing their removal; flagging for an independent editor to assess whether they belong elsewhere in the article (e.g., a treatment-landscape context) or should be detached from this sentence.

Request 5 — Typo

In the lead, "an kinase inhibitor" → "a kinase inhibitor".

Thank you for reviewing. Happy to provide full citation details, DOIs, or page numbers for any source on request. Willatbridge (talk) 02:33, 12 September 2026 (UTC)

Willatbridge (talk) 02:33, 12 September 2026 (UTC)

References