- Roche's cancer immunotherapy atezolizumab won priority review status from the FDA for the treatment of non-small cell lung cancer, the second indication for which the drug has been fast tracked, the company said on Monday.
- The FDA previously granted atezolizumab priority review for the treatment of urothelial carcinoma.
- Atezolizumab is a PD-L1 inhibitor, a class of drugs which has received increasing attention following the success of Bristol-Myers Squibb's Opdivo and Merck's Keytruda. Roche hopes to beat AstraZeneca's durvalumab to market.
Both Opdivo and Keytruda are approved for the treatment of advanced non-small cell lung cancer (NSCLC) and will be tough competition for atezolizumab. But encouraging results from anti-PD1/PD-L1 drugs (most notably former President Jimmy Carter's cancer remission after taking Keytruda) have increased market interest in the class as a whole.
Johnson and Johnson last month agreed to a collaboration study of its multiple myeloma drug Darzalex in combination with atezolizumab for the treatment of solid tumors. A week prior to the announcement with J&J, Roche teamed up with Kite Pharmaceuticals to develop the combination of atezolizumab with Kite's CAR-T therapy. The companies plan to launch a Phase 1b/2 study later this year.
Anti-PD-L1 immunotherapies work by inhibiting a protein called programmed death ligand-1 (PD-L1), which is expressed on tumor cells. The protein functions as a checkpoint on the body's immune system, limiting the ability of immune cells to target and kill the cancer. By inhibiting PD-L1, atezolizumab could boost the ability of the body to combat the cancer.
The FDA has a target action date of October 19 for an approval decision. Atezolizumab is being considered along with a companion diagnostic test to determine PD-L1 expression in patients, a similar setup as Merck's Keytruda. This has proved to be a competitive advantage for Opdivo, which doesn't carry the same diagnostic requirement.