Roche's PD-L1 inhibitor Tecentriq gains FDA approval as first-line treatment for small cell lung cancer

Roche announced Tuesday that the FDA approved Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) following priority review of the application. Sandra Horning, head of global product development at the company, noted that the PD-L1 inhibitor "is the first cancer immunotherapy" authorised in this indication.

The approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone, with median overall survival in the two groups of 12.3 months and 10.3 months, respectively. Data also showed that the Tecentriq-based combination significantly reduced the risk of disease worsening or death, with progression-free survival of 5.2 months, versus 4.3 months for chemotherapy alone.

The approval comes shortly after the FDA authorised Tecentriq, in combination with chemotherapy, for use in adults with PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. In the US, the product is also cleared in combination with Avastin (bevacizumab) and chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small-cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations, as well as being authorised for adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.

Tecentriq is also approved in the US for certain types of untreated or previously treated metastatic urothelial carcinoma in patients who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy. Sales of the product totalled 772 million francs ($772 million) in 2018.

For related analysis, see Physician Views Results - Tecentriq poised for rapid adoption in TNBC, suggest oncologists.

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