Achondroplasia is a genetic skeletal condition that results in disproportionately short stature and medical complications throughout life. Infigratinib is an orally bioavailable FGFR1–3 selective t...

From the lab bench to Phase 3 success: A major milestone for Achondroplasia research. 🧬✨ We are proud to celebrate a pivotal moment in translational medicine. BridgeBio has announced positive topline...

BridgeBio said Phase 3 PROPEL 3 data for oral infigratinib in achondroplasia were published in NEJM and support planned FDA and EMA submissions.

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Big news in rare disease: BridgeBio's infigratinib delivered standout Phase 3 results in achondroplasia. In the PROPEL 3 study, the investigational FGFR3 inhibitor: 🔹 Increased annualized growth by ...

FGFR2 has garnered attention as a promising therapeutic target for gastric cancer (GC) because of its role in GC progression. Infigratinib, an FGFR1–3 selective tyrosine kinase inhibitor, has shown potential in preclinical GC models. Methods Infigratinib was evaluated in a phase 2 trial for patients with FGFR2-amplified GC or gastroesophageal junction (GEJ) adenocarcinoma who had failed two or more lines of systemic treatment for locally advanced or metastatic disease. A total of 21 patients received 125 mg of infigratinib orally once daily on a “3 weeks on, 1 week off” schedule. Results Infigratinib showed preliminary antitumor activity in this molecularly selected population, as reflected by a confirmed objective response rate of 23.8% (95% CI, 8.2–47.2) with median progression-free survival of 3.4 months and median overall survival of 6.7 months. The most common grade 3–4 adverse events were elevated aspartate aminotransferase, decreased white blood cell count, and neutropenia. No treatment-related deaths occurred. Exploratory genomic analyses identified alterations in individual patients with disease progression that may be associated with resistance; however, these findings were based on a limited number of cases and should be interpreted as hypothesis-generating. Conclusions The findings support continued investigation of FGFR-targeted strategies in FGFR2-amplified GC/GEJ adenocarcinoma, while underscoring...

What was announced A phase 3 clinical trial published in the New England Journal of Medicine confirmed that infigratinib, an oral medication taken daily, signif

Qué se anunció Un ensayo clínico de fase 3 publicado en el New England Journal of Medicine confirmó que el infigratinib, un fármaco oral de administración diari

Phase 3 data shows infigratinib offers the first oral therapy for achondroplasia with 50–60% growth improvement, functional gains, and manageable safety—regulatory decisions expected 2024–202…

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.

Infigratinib increased growth velocity to 8.5–9.2 cm/year versus expected 5–6 cm/year in achondroplasia—a 50–60% improvement documented in Phase 3 trial data.

Phase 3 trial shows infigratinib increases growth velocity by 50–60% in children with achondroplasia, offering the first oral disease-modifying therapy for this common genetic disorder.