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Roche: FDA Oks Tecentriq Plus Chemotherapy In Initial Metastatic NSCLC Treatment

Swiss drug maker Roche Group (RHHBY) announced Wednesday that the US Food and Drug Administration approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer or NSCLC with no EGFR or ALK genomic tumour aberrations.

The approval was based on results from the Phase III IMpower130 study. It showed that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit. This means, Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone in the intention-to-treat wild-type population.

Safety for the Tecentriq plus chemotherapy combination was consistent with the known safety profiles of the individual medicines.

In lung cancer, Tecentriq is also approved in the US 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.

Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.

Roche said it has an extensive development programme for Tecentriq, including nine Phase III studies underway across different types of lung cancer. There are multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.

This includes studies evaluating Tecentriq both alone and in combination with other medicines.

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