Roche’s Tecentriq immunotherapy for SCLC treatment approved by USDFA
Category: #health  By Pankaj Singh  Date: 2019-03-20
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Roche’s Tecentriq immunotherapy for SCLC treatment approved by USDFA

The US FDA (Food & Drug Administration) has reportedly granted approval for Swiss drug-maker Roche Holding’s immunotherapy Tecentriq intended for treating ES-SCLC (Extensive Stage-Small Cell Lung Cancer). Reportedly, this is the latest win for the drug, the sales of which trail medicines from Bristol-Myers Squibb and Merck & Co.

The US regulator’s latest move comes along the heels of a recent Phase 3 Impower133 study showing that Tecentriq combined with chemotherapy (etoposide and carboplatin) appreciably helped patients live longer (a median 12.3 months) in comparison to chemotherapy alone (a median 10.3 months). Sources familiar with the development stated that around 10 to 15 per cent of lung cancers are small cell cancers, due to which tumors tend to spread at an early stage. However, the SCLC treatments are advancing gradually and Roche’s Tecentriq has been hailed as the first potential option discovered in over two decades.

Sandra Horning, Chief Medical Officer, Head of Global Product Development, Roche Holding, was reported saying that Tecentriq is the first cancer immunotherapy that has been accepted for the initial treatment of ES-SCLC, which is a difficult-to-treat cancer type. Horning further added that there has been limited progress in the treatment of this disease so far, and the company is excited to be introducing a new standard of care for patients that holds more potential to improve survival.

Reportedly, the Phase 3 Impower133 study is multi-center, randomised placebo-controlled and double-blinded, which assesses the safety and efficiency of Tecentriq, in conjunction with chemotherapy. The study had enrolled around 403 patients who were equally randomised to receive Tecentriq combined with carboplatin & etoposide in Arm A, and then placebo combined with the same in Arm B and control Arm. The co-primary endpoints were PFS (progression-free survival) as established by the investigator. 

Authentic reports further mentioned that Tecentriq received $766 million in revenue in 2018, while Bristol- Myers’ Opdivo and Merck’s Keytruda immunotherapy gained $6.7 billion and $7.2 billion respectively in the same year.



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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