Roche’s atezolizumab gets fast US review in lung cancer

Genentech’s atezolizumab has been granted a fast review in the US for some cases of advanced non-small cell lung cancer.

The US Food and Drug Administration has granted a Priority Review for the anti-PDL1 drug for treatment of people with locally advanced or metastatic non-small cell lung cancer, whose disease express the protein PD-L1 (programmed death ligand-1), and who have progressed on or after platinum-containing chemotherapy.

The Roche unit’s drug was granted Breakthrough Therapy designation by the FDA in February 2015, and the new announcement means the drug’s accelerated review process continues.

This means the drug could be approved within just a few months.

That’s good news for Roche, which needs to catch up with the two market leaders in cancer immunotherapy, BMS’s Opdivo and Merck’s Keytruda. Both are already approved for advanced melanoma and non-small cell lung cancer (NSCLC), Opdivo gaining approval in lung cancer in March 2015 and Keytruda in October last year.

The filing is based on results from clinical trials including the Phase II BIRCH study and the FDA will make a decision by October 19.

Roche Tissue Diagnostics has also filed a companion PD-L1 test with the FDA to accompany the drug.

The FDA granted a breakthrough therapy designation for atezolizumab in locally advanced or metastatic urothelial carcinoma (mUC) in 2014, and the company expects to file it for this indication imminently.

Amgen last year announced a collaboration with Roche evaluation its Imlygic (talimogene laherparepvec) in combination with atezolizumab in triple-negative breast cancer and colorectal cancer with liver metastases.

Evaluate Pharma has forecast annual atezolizumab sales of around $2.6 billion for atezolizumab in 2020.

Related stories:

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