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FDA rejects sintilimab for NSCLC

 Last Update: 2022-04-23
 Source: Internet
 Author: User

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Sintilimab has been approved in China under the name Tyvyt for first-line treatment of non-squamous non-small cell lung cancer and third-line treatment of relapsed or refractory classical Hodgkin lymphoma
.
Eli Lilly and Innovent initially partnered to develop sintilimab in 2015, and the deal has since expanded to include markets outside of China

Lung cancer lymphoma

Eli Lilly announced today that the FDA has issued a complete response letter (CRL) regarding the marketing application seeking approval for sintimab in certain non-small cell lung cancer ( NSCLC ) patients
.
The FDA advisory committee voted that Eli Lilly and its partner Innovent Bio should More trials of sintilimab

FDA NSCLC

The companies are seeking approval of sintilimab in combination with chemotherapy for first-line treatment of adults with stage IIIB, IIIC or IV non-squamous non-small cell lung cancer
.
The application is based on the results of the Phase III ORIENT-11 trial, which was conducted entirely in China

As of November 15, 2019, median follow-up was 8.

Figure 1.

PFS of sintilimab combination group and placebo combination group

Figure 1.

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