Infigratinib receives accelerated approval from the FDA for metastatic cholangiocarcinoma

Share This Post

August 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor, has been granted accelerated approval by the Food and Drug Administration for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

The FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.) as a companion diagnostic device for infigratinib treatment in patients with FGFR2 fusion or additional rearrangements.

CBGJ398X2204 (NCT02150967), a multicenter open-label single-arm trial with 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as verified by local or central tests, demonstrated efficacy. Infigratinib 125 mg orally once daily for 21 days, followed by 7 days off therapy, was given to patients in 28-day cycles until disease progression or unacceptable toxicity.

Overall response rate (ORR) and duration of response (DoR) were the primary efficacy outcome measures, as established by a blinded independent central review in accordance with RECIST 1.1. With 1 complete response and 24 partial responses, the ORR was 23% (95 percent CI: 16, 32). The average DoR was 5 months (95 percent CI: 3.7, 9.3). Eight of the 23 responders kept their answer for six months or longer.
Hyperphosphatemia, increased creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhoea, dry skin, decreased appetite, vision blurred, and vomiting were the most common adverse reactions (incidence 20%). Hyperphosphatemia and retinal pigment epithelial detachment are major hazards, and patients should be monitored for these side effects during treatment.

You may like to read : Cancer treatment in India

In 28-day cycles, the recommended infigratinib dose is 125 mg orally once day on an empty stomach for 21 days, followed by 7 days off medication.


Check details here.

Take second opinion on cholangiocarcinoma treatment

Send Details

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

How Targeted Therapy is Revolutionizing Advanced Cancer Treatment

How Targeted Therapy is Revolutionizing Advanced Cancer Treatment?

In the field of oncology, the emergence of targeted therapy has revolutionized the treatment landscape for advanced cancers. Unlike conventional chemotherapy, which broadly targets rapidly dividing cells, targeted therapy aims to selectively attack cancer cells while minimizing damage to normal cells. This precision approach is made possible by identifying specific molecular alterations or biomarkers that are unique to cancer cells. By understanding the molecular profiles of tumors, oncologists can tailor treatment regimens that are more effective and less toxic. In this article, we delve into the principles, applications, and advancements of targeted therapy in advanced cancer.

Utilizing Immunotherapy to Treat Late-Stage Cancers

Utilizing Immunotherapy to Treat Late-Stage Cancers

  Introduction Immunotherapy has become a groundbreaking method in cancer treatment, especially for advanced-stage cancer treatments that have demonstrated minimal effectiveness with standard medicines. This

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy