Roche Voluntarily Withdraws Another U.S. Indication for Tecentriq, Narrowing Its Therapeutic Scope

　　【Pharmaceutical Network Enterprise NewsRecently, Roche voluntarily withdrew the indication for its PD-L1 monoclonal antibody atezolizumab (Tecentriq) in the United States for the treatment of patients with metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
 

Public information shows that Atezolizumab is a PD-L1 immune checkpoint inhibitor independently designed and developed by Roche. It can directly bind to the PD-L1 ligand protein expressed on tumor cells and tumor-infiltrating immune cells, blocking the interaction between PD-L1 and the PD-1 and B7.1 receptors on immune cells, effectively activating T cells to recognize and kill tumor cells.
 

Currently, the main approved indications for Atezolizumab in and outside China include: On May 18, 2016, the U.S. FDA approved Atezolizumab for the treatment of urothelial carcinoma (the most common type of bladder cancer) that is resistant or has progressed after adjuvant or neoadjuvant platinum-based chemotherapy, making it the world's first approved PD-L1 monoclonal antibody.
 

On April 17, 2017, the FDA granted accelerated approval to atezolizumab for the initial treatment of patients with advanced bladder cancer who are ineligible for cisplatin-based therapy.
 

On December 6, 2018, the FDA approved atezolizumab in combination with chemotherapy and bevacizumab for the treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).
 

On February 25, 2019, Atezolizumab was filed for marketing approval in China, becoming the second PD-L1 inhibitor to be submitted for marketing authorization in China after AstraZeneca's Durvalumab; On March 8, the FDA approved Atezolizumab in combination with nab-paclitaxel as a first-line treatment for advanced or metastatic triple-negative breast cancer with PD-L1 expression ≥ 1%; this made it the first immune checkpoint inhibitor approved for the treatment of breast cancer; On December 3, Atezolizumab received FDA approval in combination with nab-paclitaxel and carboplatin for the first-line treatment of advanced NSCLC.
 

On July 30, 2020, the FDA approved Atezolizumab in combination with Cobimetinib and Vemurafenib for the treatment of BRAF V600 mutation-positive advanced melanoma; On February 13, Atezolizumab was initially approved in China in combination with chemotherapy (carboplatin and etoposide) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); On October 28, Atezolizumab was approved in China in combination with Bevacizumab for first-line treatment of unresectable hepatocellular carcinoma (HCC) patients who had not previously received systemic therapy; On May 18, Atezolizumab received FDA approval for first-line treatment of PD-L1 high-expressing EGFR/ALK-negative advanced NSCLC.
 

On April 29, 2021, Atezolizumab was approved in China for first-line monotherapy in patients with high PD-L1 expression and no EGFR or ALK gene mutations in metastatic non-small cell lung cancer (NSCLC). On June 22, it was approved in China in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC without EGFR and ALK gene mutations.
 

Notably, prior to this withdrawal of the new indication, Roche also withdrew the indication for atezolizumab as a second-line treatment for patients with metastatic urothelial carcinoma who had progressed after receiving platinum-based chemotherapy. Industry insiders believe this signifies a further reduction in the drug's scope of application in the United States and Europe.
 

In fact, the withdrawal of indications is not uncommon in pharmaceutical companies. Especially since the end of last year, the FDA began to crack down on the cleanup of PD-1/L1 drugs that were approved through accelerated approval but failed to show sufficient efficacy in subsequent confirmatory clinical trials. At present, in addition to Roche, Bristol-Myers Squibb, Merck, AstraZeneca, and others have also started to voluntarily withdraw the indications for confirmatory clinical trials where their respective PD-1/L1 antibodies did not pass. In the future, as the FDA review becomes increasingly stringent, this situation is expected to occur frequently within the industry.
 

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