Roche’s Tecentriq gets fast review in triple negative breast cancer

The FDA has granted a fast review for Roche/Genentech’s Tecentriq in combination with Celgene’s Abraxane for certain patients with tough-to-treat ‘triple negative’ breast cancer. The regulator has granted the immunotherapy Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) a faster six-month review for unresectable locally advanced or metastatic triple negative breast cancer (TNBC). Patients would be tested to see if their tumours express the protein PD-L1 to ensure they are eligible for treatment.
If approved, Tecentriq will be the first immunotherapy available for patients with this kind of disease, allowing Roche a free run at the indication without competition from rival immunotherapies such as Merck & Co’s Keytruda and Bristol-Myers Squibb’s Opdivo. The FDA is expected to make a decision on the combination by March 12 next year, and the regulator has agreed to a faster six-month Priority Review reserved for drugs that could provide significant improvements in treatment, prevention, or diagnosis of a disease. Standard reviews the last ten months.