The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA is expected to make a decision on approval by
'New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,' said
This application is based on disease-free survival (DFS) results from an interim analysis of the Phase III IMpower010 study, the first and only Phase III study of a cancer immunotherapy to demonstrate positive results in the adjuvant lung cancer setting. The study showed that treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA NSCLC whose tumors express PD-L11%, compared with best supportive care (BSC). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC. Follow-up on the IMpower010 trial will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, including Stage IB patients, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Results from the IMpower010 trial were presented at the 2021 ASCO Annual Meeting.
About the IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.
About lung cancer
According to the
About Tecentriq(atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq
Tecentriq is a prescription medicine used to treat adults with: A type of lung cancer called non-small cell lung cancer (NSCLC).
Tecentriq may be used alone as their first treatment when their lung cancer: has spread or grown, and their cancer tests positive for 'high PD-L1', and their tumor does not have an abnormal 'EGFR' or 'ALK' gene
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called 'non-squamous NSCLC,' and their tumor does not have an abnormal 'EGFR' or 'ALK' gene Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called 'non-squamous NSCLC,' and their tumor does not have an abnormal 'EGFR' or 'ALK' gene Tecentriq may also be used when their lung cancer: o has spread or grown, and o they have tried chemotherapy that contains platinum, and it did not work or is no longer working o if their tumor has an abnormal 'EGFR' or 'ALK' gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working A type of lung cancer called small cell lung cancer (SCLC).
Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer: is a type called 'extensive-stage small cell lung cancer,' which means that it has spread or grown It is not known if Tecentriq is safe and effective in children.
Important Safety Information
What is the most important information about Tecentriq
Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.
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