The approval has been granted for Tecentriq in combination with Abraxane (paclitaxel protein-bound; nab-paclitaxel) and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumour aberrations.
The FDA approval was based on the data from the phase III IMpower130 study, which demonstrated Tecentriq in combination with chemotherapy helped people live significantly longer compared against chemotherapy alone in the intention-to-treat wild-type (ITT-WT) population.
Tecentriq-based combination also significantly minimised the risk of disease worsening or death compared with chemotherapy alone in the ITT-WT population, said the company.
The IMpower130 is a phase III, multicentre, open-label, randomised study assessing the efficacy and safety of Tecentriq in combination with nab-paclitaxel and carboplatin versus chemotherapyalone for chemotherapy-naïve patients with stage IV non-squamous NSCLC.
Roche recruited 724 people, of which 681 were in the ITT-WT population and were randomised (2:1) to receive Tecentriq plus nab-paclitaxel and carboplatin and Nab-paclitaxel and carboplatin.
The FDA also approved Tecentriq in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.
Also, the FDA approved Tecentriq to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.
Tecentriq is being assessed in nine Phase III studies with different types of lung cancer, as well as multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.
Roche chief medical officer and global product development head Dr 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 the disease.”
In October this year, Roche secured FDA approval for its Xofluza (baloxavir marboxil) to treat people at high risk of developing influenza-related complications.