The day before, the U.S. Food and Drug Administration (FDA) approved the PD-1 accelerated Nivolumab antibody (Opdivo) for the treatment of first-line platinum based chemotherapy within one year progression of locally advanced or metastatic urothelial carcinoma patients.

Bladder cancer is one of the most common malignant tumors in the Department of urology. It is a serious disease that directly threatens the life life and quality of life of the patients. The most common type of bladder cancer is urothelial carcinoma, which accounts for more than 90% of the pathological types of bladder cancer.

For patients with bladder cancer who failed late chemotherapy, the options were limited. The rise of immunotherapy, represented by PD-1/PD-L1 antibodies, has brought the gospel to patients with advanced bladder cancer.

The approval of Nivolumab, is based on CheckMate-275 single arm clinical study, the study included 270 patients with locally advanced or metastatic transitional cell carcinoma patients during chemotherapy, platinum containing drugs after chemotherapy or neoadjuvant treatment with platinum drugs within 12 months of disease progression, given the Nivolumab 3mg/kg every 2 weeks / treatment until disease progression or unacceptable toxicity.

The results showed that the objective response rate of Nivolumab was 19.6% (53/270). There were 7 patients with complete response, and 46 patients had partial response. The median duration of response was estimated for 10.3 months.

The most common adverse reactions (&le, 20%) were fatigue, musculoskeletal pain, nausea and decreased appetite, and their safety was consistent with other approved tumor types.

For this application of Nivolumab, FDA gave it to “ a breakthrough therapy ” and gave priority to approval. The application time was approved 1 months in advance.

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It is worth mentioning that PD-1 antibodies have been listed in 2014 and have been approved for a variety of cancer indications:

(1) melanoma that can not be excised or metastasised;

2. Metastatic non-small cell lung cancer treated with first-line chemotherapy /TKI after failure.

(3) advanced renal cell carcinoma treated with vascular inhibitor;

(4) the recurrent or progresses of classical Hodgkin's lymphoma after autologous stem cell transplantation or Brentuximab vedotin treatment;

(5) relapse or metastatic head and neck squamous cell carcinoma with platinum group chemotherapy failure.

PD-1 antibody is used to sweep all the big tumors with a super black horse posture. It contributes the largest anti-tumor feast. It has become the &ldquo of cancer treatment field and &rdquo. It not only provides a new way for cancer patients who fail in traditional treatment, but also helps to open up a new pathway for patients who are helpless at the later stage, which is an important weapon to prolong the survival time of patients.