Tislelizumab Drug News

In December 2019, Tislelizumab was approved by the National Medical Products Administration (NMPA) for the treatment of relapsed or refractory classical Hodgkin lymphoma that has received at least second-line systemic chemotherapy.

In April 2020, Tislelizumab was approved by the NMPA for the treatment of locally advanced or metastatic PD-L1-high expressing urothelial carcinoma that progressed within 12 months after failure of platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy.

In January 2021, Tislelizumab was approved by the NMPA for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer, in combination with paclitaxel and carboplatin, or paclitaxel (albumin-bound) for injection and carboplatin.

In June 2021, Tislelizumab was approved by the NMPA for the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer with negative epidermal growth factor receptor (EGFR) gene mutation and negative anaplastic lymphoma kinase (ALK), in combination with pemetrexed and platinum-based chemotherapy.

In June 2021, Tislelizumab was approved by the NMPA for the treatment of hepatocellular carcinoma (HCC) that has received at least one line of systemic therapy.

In January 2022, Tislelizumab was approved by the NMPA for the second- or third-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that progressed after platinum-based chemotherapy.

In March 2022, Tislelizumab was approved by the NMPA for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors in adult patients.

In April 2022, Tislelizumab was approved by the NMPA for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that progressed or was intolerable after first-line standard chemotherapy.

In June 2022, Tislelizumab was approved by the NMPA for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, in combination with gemcitabine and cisplatin.

In February 2023, Tislelizumab was approved by the NMPA for the first-line treatment of PD-L1-high expressing locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with fluoropyrimidine-based and platinum-based chemotherapy.

In May 2023, Tislelizumab was approved by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), in combination with chemotherapy.

In January 2024, Tislelizumab was approved by the NMPA for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).

In June 2024, Tislelizumab was approved by the NMPA for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide and platinum-based chemotherapy.

In October 2024, Tislelizumab was approved by the NMPA for neoadjuvant therapy in combination with platinum-based chemotherapy, followed by single-agent adjuvant therapy with Tislelizumab after surgery, for patients with resectable stage II or stage IIIA non-small cell lung cancer.