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December 4, 2019

Roche secures FDA approval for Tecentriq combination in lung cancer

Roche has received the US Food and Drug Administration (FDA) approval to use Tecentriq (atezolizumab) plus Abraxane and carboplatin chemotherapy to treat non-small cell lung cancer (NSCLC) patients.

Roche has received the US Food and Drug Administration (FDA) approval to use Tecentriq (atezolizumab) plus Abraxane and carboplatin chemotherapy to treat non-small cell lung cancer (NSCLC) patients.

Approval is for adults with metastatic non-squamous NSCLC without EGFR or ALK genomic tumour irregularities.

Tecentriq is an immunotherapy drug that binds to PD-L1 and prevents its interaction with PD-1 and B7.1 receptors to activate T-cells, being developed for the treatment of various cancers.

FDA approval is supported by data from the Phase III IMpower130 clinical trial, which compared the Tecentriq combination to chemotherapy alone in a total of 724 patients who had not received chemotherapy previously.

Data showed that the combination therapy led to a median overall survival of 18.6 months compared to 13.9 months with only chemotherapy in the intention-to-treat wild-type (ITT-WT) patient population.

Furthermore, Tecentriq plus Abraxane and carboplatin was observed to decrease the risk of disease worsening or death, with 7.2 months of progression-free survival versus 6.5 months when treated with Abraxane and carboplatin alone.

Safety analysis of the combination revealed consistency with the known profiles of specific drugs. Investigators had not reported any extra safety signals for the combination.

Roche chief medical officer and Global Product Development head Levi Garraway said: “We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer.

“Today’s approval offers another opportunity to help prolong the lives of people with this type of disease.”

In the US, Tecentriq already holds approval to treat adults with metastatic non-squamous NSCLC without EGFR or ALK genomic tumour aberrations, in combination with Avastin, paclitaxel and carboplatin.

The drug can also be used for adults suffering from metastatic NSCLC and have disease progression during or after platinum-containing chemotherapy.

It is also indicated in combination with carboplatin and etoposide as first-line therapy for adults with extensive-stage small cell lung cancer (ES-SCLC) in the US.

 

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