The US FDA has approved F. Hoffmann-La Roche AG’s Tecentriq combined with Celgene’s Abraxane as the first immunotherapy drug for triple negative breast cancer, an aggressive form of breast cancer.
The Swiss drugmaker Roche revealed that the FDA had granted accelerated approval to the PD-L1 checkpoint inhibitor Tecentriq (atezolizumab), combined with Celgene’s Abraxane (nab-paclitaxel), for TNBC that cannot be removed with surgery and is locally advanced or metastatic. The FDA has also approved a companion diagnostic, Ventana PD-L1 Assay, also developed by Roche, for detecting the immune checkpoint in TNBC patients. The current approval of this drug is only for TNBC patients whose cancers express PD-L1.
Representing 15 percent of all breast cancer cases diagnosed, TNBC is diagnosed in approximately 300,000 women globally. This type of breast cancer does not express estrogen receptor, progesterone receptor or HER2 genes, drugs that target it do not work, and nor do hormone therapies.The disease is thus typically treated with a combination of surgery, radiation and chemotherapy.
The data from Phase III IMpassion130 study, involving 902-patients, was used for the approval. The study showed that the combination of Tecentriq with Abraxane produced a progression-free survival of patients for upto 7.4 months compared to the 4.8 months seen with the use of Abraxane alone.
“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic, triple-negative breast cancer, a disease with high unmet medical need,” Roche’s chief medical officer Sandra Horning said in a press statement. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease,” she added.
Tecentriq was already approved for non-small cell lung cancer and urothelial carcinoma, with the latter indication also under accelerated approval.