Roche-group Genentech’s anti-PDL1 cancer immunotherapy Tecentriq has been approved in the US to treat certain forms of lung cancer, expanding its scope from the original bladder cancer indication.
The US Food and Drug Administration has cleared the drug’s use to treat advanced non-small cell lung cancer (NSCLC) in patients in whom platinum-containing chemotherapy has failed or is failing, regardless of their PD-L1 status.
The decision, which makes Tecentriq (atezolizumab) the first and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic NSCLC, is based on data from the randomised Phase III OAK and Phase II POPLAR studies.
The OAK trial showed that the drug helped people in the overall study population live a median of 13.8 months, 4.2 months longer than given docetaxel chemotherapy (median overall survival [OS]: 13.8 versus 9.6 months). Median OS in the POPLAR study was 12.6 months and 9.7 months, respectively.
“Over the past 15 years, survival rates for advanced lung cancer have been consistently improving,” said lung cancer survivor Bonnie Addario, founder of the Bonnie Addario Lung Cancer Foundation (ALCF). “The approval of Tecentriq is another important step for patients by increasing the number of medicines available to people living with lung cancer.”
The drug’s development programme includes more than 15 clinical trials in lung cancer, including seven late-stage trials assessing its first-line use both alone or in combination with other medicines.
Tecentriq was approved in the US to treat locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy back in May.
