FDA gives priority review to Roche’s Tecentriq for breast cancer type

Roche Holding AG, the Swiss drugmaker has announced that U.S. regulators would be giving its Tecentriq medicine a speedy review for use in a form of tough-to-treat breast cancer. Roche is looking to become the first company to win approval for its immunotherapy in this application.

Roche stated that the United States Food and Drug Administration (FDA) has given priority review to Tecentriq in combination with chemotherapy Abraxane for the initial treatment of people suffering from metastatic triple-negative breast cancer. The tumors in these patients test positive for the PD-L1 protein which helps the tumors avoid being detected by the immune system.

Roche’s chief medical officer, Sandra Horning said this type of breast cancer is hard to treat and patients need more treatment options for it. Roche is aiming to be the first-to-market in treatment areas that are small but lucrative, as Tecentriq sales are trailing behind the immunotherapies from Bristol-Myers Squibb and Merck in the main type of lung cancer.

Experts say the triple-negative tumors, which account for 15 percent of breast cancer cases, provide such an opportunity for Roche. Apparently, Roche has won the accelerated review from FDA in only a subset of patients, that is the approx. 40 percent of its patients in the study whose tumors exhibited high levels of the protein PD-L1.

Records from the interim overall survival data disclosed for these patients last month at a medical conference in Germany showed they lived a median of 25 months. These numbers are high in comparison with just 15.5 months for the patients who got only chemotherapy.

Considering all the 902 patients involves in Roche’s study, those getting the Tecentriq combination lived a median of 21.3 months so far, as opposed to 17.6 months for those only on chemotherapy, the company had informed. Roche is expecting that, with the priority review, a decision will be given by March 12.