Companion test for lung cancer approved by FDA

pharmafile | October 22, 2021 | News story | Medical Communications  

The US FDA has approved of the Roche VENTANA PD-L1 Assay as a companion diagnostic for Tecentriq® in non-small cell lung cancer patients.

The VENTANA PD-L1 Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy, based on the results of the Phase III Impower010 study. This advances the company’s commitment to guide clinical decision-making through innovative, high quality assays that improve patient access to personalised healthcare.

“Early detection of lung cancer can change the treatment pathways for patients and give them more treatment options,” said Thomas Schinecker, CEO of Roche Diagnostics. “We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for Tecentriq therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment.”

Currently, surgery to remove tumors is the standard treatment for early-stage lung cancer patients, which can be followed by chemotherapy. However, the cancer is found to return following an operation in about half of patients. The availability of immunotherapy gives patients and doctors a tool to reduce risk of cancer recurrence and cancer relapse.

Lung cancer remains the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer accounts for 80-85% of all lung cancers.

Tecentriq received FDA approval on 15 October, as adjuvant treatment  for non-small cell lung cancer patients. This provides those diagnosed with early lung cancer the opportunity to receive immunotherapy and increase their chances for a cure.

Roche Diagnostics develop innovative products and services that address the prevention, diagnosis, monitoring, screening, and treatment of diseases.

Ana Ovey

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