PD-1 goes to sea!

On September 13, BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
for the treatment of past systems by treatment of unresectable, locally advanced or metastatic recurrence of esophageal squamous cell carcinoma (of ESCC) patients
.

According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the application for the marketing ofBezeran® is July 12, 2022

Unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment July 12, 2022

The listing application is a joint application by Baekje and Novartis, based on the results of a randomized, open, multi-center global phase 3 clinical trial RATIONALE 302 (NCT03430843) , which aims to evaluate the choice of researchers for the comparison of Bazeran® The effectiveness and safety of advanced chemotherapy for second-line treatment of patients with advanced or metastatic ESCC
.

The test results have been announced on ASCO 2021

This listing application is a joint application by Baekje and Novartis.

Application status of tislelizumab indications in China

Source: Insight database compilation

Esophageal cancer is one of the most common malignant tumors in the gastrointestinal tract, mainly divided into squamous cell carcinoma and adenocarcinoma
.

At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy

The RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial (NCT03430843), which aims to evaluate the effectiveness and safety of Baizian® versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic ESCC Sex
.

The primary end point of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary end point is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).

The RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial (NCT03430843), which aims to evaluate the effectiveness and safety of Baizian® versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic ESCC Sex

RATIONALE 302 has fully considered the research design.

The research team also fully considered the differences in clinical practice in different countries and regions, making the overall research results into high-level evidence-based medicine evidence applicable to different countries

The primary endpoint of the study is the intention-to-treat (ITT) population with a median overall survival (OS) of 8.

It is worth noting that RATIONALE 302 is not only the first global study of esophageal squamous cell carcinoma, but also the only phase 3 study that benefits the whole population in the world

Jun fact of Terry Plymouth mAb line & third-line treatment of nasopharyngeal carcinoma Cinda letter Dealey monoclonal antibody -line treatment of non-squamous NSCLC Kang party / faction sunny Puli mAb third-line treatment of nasopharyngeal carcinoma

This time BeiGene's tislelizumab also took an important step towards the sea
.

This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.