Fruquintinib is approved by the USFDA in refractory metastatic colorectal cancer

Fruquintinib is approved by the USFDA in refractory metastatic colorectal cancer

Share This Post

The Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) on November 8, 2023, for adult patients with metastatic colorectal cancer (mCRC) who have undergone specific prior treatments.

Efficacy was assessed in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819). The FRESCO-2 trial (NCT04322539) assessed 691 patients with mCRC who experienced disease progression after previous fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF biological therapy, anti-EGFR biological therapy (if RAS wild type), and at least one of trifluridine/tipiracil or regorafenib. It was an international, multicenter, randomized, double-blind, placebo-controlled study. The FRESCO trial, a multicenter study in China, assessed 416 patients with metastatic colorectal cancer who experienced disease progression following previous fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy.

In both trials, patients were randomly assigned to either get fruquintinib 5 mg orally once a day or a placebo for the first 21 days of each 28-day cycle. They also got the best possible supportive care. Patients were treated until disease progression or unacceptable toxicity occurred.

The primary effectiveness outcome in both trials was overall survival (OS). The median overall survival in the fruquintinib group was 7.4 months (95% CI: 6.7, 8.2) compared to 4.8 months (95% CI: 4.0, 5.8) in the placebo group. The hazard ratio was 0.66 (95% CI: 0.55, 0.80) with a p-value of less than 0.001. The median overall survival (OS) in the FRESCO study was 9.3 months (95% CI: 8.2, 10.5) and 6.6 months (95% CI: 5.9, 8.1) in the different treatment groups. The hazard ratio (HR) was 0.65 (95% CI: 0.51, 0.83) with a statistically significant p-value of less than 0.001.

The prevalent side effects (experienced by 20% or more of patients) included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

The suggested fruquintinib dosage is 5 mg taken orally once a day, with or without food, for the initial 21 days of a 28-day cycle until disease progression or intolerable toxicity.

View full prescribing information for fruquintinib.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

CAR T Cell therapy for AIDS related B Cell malignancies
Aids cancer

CAR T Cell therapy for AIDS related B-Cell malignancies

CAR T cell therapy for HIV-related B cell malignancies involves genetically modifying a patient’s T cells to express chimeric antigen receptors (CARs) targeting CD19 on B cells. This treatment holds promise in eradicating malignant B cells but must carefully manage immunosuppression in HIV-positive individuals.

Cancer statistics in India 2024

Cancer statistics in India 2024: Incidence, estimates and projections

In 2024, cancer will remain a significant health challenge in India. The country sees over 1.5 million new cases a year. Breast and oral cancers are most prevalent among women and men, respectively. Sadly, many cases are diagnosed late, impacting survival rates. Improved awareness and access to healthcare are crucial. By 2030, cancer incidence is expected to surpass 1.7 million cases annually. Efforts to enhance prevention, early detection, and treatment access are crucial to mitigate this growing burden. Check our cancer statistics in India for 2024 and future projections.

Need help? Our team is ready to assist you.

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

Start chat
Need help with cancer treatment?
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