Nivolumab has been approved by the FDA for use as an adjuvant treatment for urothelial carcinoma

Share This Post

August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence following radical resection.

This is the first time the FDA has approved an adjuvant treatment for high-risk UC patients. The findings also backed up the decision to convert nivolumab’s accelerated authorisation for advanced/metastatic UC to a standard approval.

Nivolumab was studied in CHECKMATE-274 (NCT02632409), a randomised, double-blind, placebo-controlled trial in patients with UC of the bladder or upper urinary tract (renal pelvis or ureter) who were at high risk of recurrence within 120 days of radical resection. Patients were randomly assigned (1:1) to receive nivolumab 240 mg or placebo by intravenous infusion every two weeks until recurrence or intolerable toxicity, with a maximum treatment period of one year.

In the intent-to-treat (ITT) group and in patients with tumours expressing PD-L1 less than 1%, the primary effectiveness objective was investigator-assessed disease-free survival (DFS). Time to first recurrence (local urothelial tract, local non-urothelial tract, or distant metastatic) or death was used to determine DFS. For all primary objectives, a statistically significant improvement in DFS was reported in participants on the nivolumab arm vs. placebo at a prespecified interim analysis. In the ITT analysis, patients who got nivolumab had a median DFS of 20.8 months (95 percent CI: 16.5, 27.6) compared to 10.8 months (95 percent CI: 8.3, 13.9) in patients who received placebo (HR 0.70; 95 percent CI: 0.57, 0.86; p=0.0008). Patients who received nivolumab had a median DFS of not achieved (95 percent confidence interval: 21.2, not estimable) compared to 8.4 months (95 percent confidence interval: 5.6, 21.2) for those who got placebo (HR 0.55; 95 percent confidence interval: 0.39, 0.77; p=0.0005).

The unstratified DFS hazard ratio estimate was 0.83 in an exploratory examination of patients with PD-L1-negative tumours (58 percent) (95 percent CI: 0.64, 1.08). With 33 percent of deaths in the entire randomised population, OS data is still in its infancy. There were 37 deaths in the UTUC subpopulation (20 in the nivolumab arm, 17 in the placebo arm).

Rashes, weariness, diarrhoea, pruritus, musculoskeletal pain, and urinary tract infection were the most prevalent adverse effects observed in approximately 20% of participants who received nivolumab in CHECKMATE-274.

Nivolumab is prescribed at a dose of 240 mg every two weeks or 480 mg every four weeks for the adjuvant treatment of UC.



Check details here.

Take second opinion on urothelial carcinoma treatment

Spread the love

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Development of CAR T Cell therapy in Korea
Cancer treatment in South Korea

Companies in Korea takes a step closer in developing home grown CAR T-Cell therapy

Due to high costs, treatments developed by multinational pharmaceutical corporations are difficult for Korean patients to access. As a result, Korean businesses have created and localised CAR-T treatments in an effort to address these issues. Many businesses have either begun developing CAR-T therapies or declared their intention to do so, including Curocell, Abclon, GC Cell, Ticaros, Helixmith, Toolgen, Cllengene, Eutilex, and Vaxcell Bio.

Spread the love
Blood cancer

Polatuzumab vedotin-piiq is approved by USFDA for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

For adult patients with high-grade B-cell lymphoma (HGBL), not otherwise specified (NOS), or diffuse large B-cell lymphoma (DLBCL) who have not previously received treatment and who have an International Prognostic Index (IPI) score of 2 or higher, the Food and Drug Administration has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.).

Spread the love

Need help? Our team is ready to assist you.

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

درمان سرطان در تركيه

Enquiry Form