FDA OKs new indication for Roche’s Tecentriq

The Food and Drug Administration has greenlighted Roche's Tecentriq (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test.

“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”

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“Too many patients with early-stage lung cancer experience disease recurrence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse,” said Bonnie Addario, co-founder and chair, GO2 Foundation for Lung Cancer. “With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.”

Tecentriq previously has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications.

In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy).

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Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.

Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.