On September 05 2018, Roche reported that it was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months (Press release, Hoffmann-La Roche, SEP 5, 2018, View Source [SID1234529354]). The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by December 05, 2018. In May 2018, TECENTRIQ in combination with Avastin, carboplatin and paclitaxel was granted Priority Review from the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the Phase III IMpower150 study.
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About NSCLC
Lung cancer is the leading cause of cancer death globally.[1] Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[2] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.[3]
About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved across several types of cancers including advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and recurrent glioblastoma. Avastin is approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.
About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.