FDA Approved Truseltiq for Metastatic Cholangiocarcinoma with the FGFR2 Biomarker

JHOP - August 2021 Vol 11, No 4 - FDA Oncology Update
Download PDF

On May 28, 2021, the FDA accelerated the approval of infigratinib (Truseltiq; QED Therapeutics), an oral kinase inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) and FGFR2 fusion or other rearrangement, as detected by an FDA-approved test.

The FDA granted infigratinib priority and fast-track review, as well as orphan drug designation for this indication. Infigratinib is the second targeted therapy approved by the FDA for this patient population.

On the same day, the FDA approved the FoundationOne CDx test as a companion diagnostic to infigratinib for selecting patients with CCA and FGFR2 fusion or other rearrangement for infigratinib treatment.

The approval of infigratinib was based on results from CBGJ398X2204, a multicenter, open-label, single-arm clinical trial of 108 patients with previously treated, unresectable locally advanced or metastatic CCA and an FGFR2 fusion or rearrangement. Patients received infigratinib 125 mg once daily for 21 days, followed by 7 days off, in 28-day cycles, until disease progression or unacceptable side effects.

The primary end points were overall response rate (ORR) and duration of response (DOR). The ORR was 23% (95% confidence interval [CI], 16-32), including 1 complete response and 24 partial responses. The median DOR was 5 months (95% CI, 3.7-9.3). Among the 23 patients who responded to therapy, the DOR was ≥6 months in 8 patients.

The most common (≥20%) adverse reactions were hyperphosphatemia, increased creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting. Grade 3 or 4 adverse events included hyperphosphatemia and retinal pigment epithelial detachment.

Continued approval for this indication may be contingent on clinical benefit in confirmatory trial(s).

Related Items
FDA-Approved Nirogacestat Demonstrates Improved Patient Outcomes in Desmoid Tumor Management
Web Exclusives published on February 12, 2024 in FDA Oncology Update
Iwilfin FDA Approved for Adults and Pediatric Patients with High-Risk Neuroblastoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Welireg Now FDA Approved for Patients with Advanced Renal Cell Carcinoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of Advanced Gastroesophageal Junction Adenocarcinoma
Web Exclusives published on December 19, 2023 in FDA Oncology Update
FDA Approved Loqtorzi, a PD-1 Inhibitor, for the Treatment of Adults With Metastatic or Recurrent Nasopharyngeal Carcinoma
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Tibsovo FDA Approved for Patients With Relapsed Myelodysplastic Syndromes and IDH1 Mutation
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Fruzaqla FDA Approved for Refractory Metastatic Colorectal Cancer
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
Rozlytrek Now Approved for Pediatric Patients Older Than 1 Month With Solid Tumors and NTRK Gene Fusion and in New Oral Pellet Form
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
FDA Authorizes Updated COVID-19 Vaccine Formulations for Better Protection Against Current Variants
JHOP - December 2023 Vol 13, No 6 published on November 17, 2023 in FDA Oncology Update
Bosulif Now FDA Approved for Pediatric Patients With Chronic Myelogenous Leukemia
JHOP - December 2023 Vol 13, No 6 published on November 3, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: