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Bristol-Myers Squibb has announced its decision to withdraw a supplemental biologics license application currently with the FDA seeking frontline approval for the combination of nivolumab and ipilimumab for patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
A retrospective analysis of survival data from patients with metastatic non–small cell lung cancer showed that patients who received treatment at academic centers had better survival rates than those treated at community-based centers, and this disparity was more pronounced when patients were stratified by histology.
A supplemental biologics license application submitted to the FDA for atezolizumab, carboplatin, and nab-paclitaxel has been accepted. The application, based on findings from the phase III IMpower130 trial, is seeking the agent's approval for patients with metastatic nonsquamous non–small cell lung cancer.
Increasing clinical relevance of less common gene signatures and alterations is leading to a benefit from broad-panel next-generation sequencing testing for patients with metastatic non–small cell lung cancer, according to an expert at Memorial Sloan Kettering Cancer Center.
The use of big data is revolutionizing many industries, allowing greater insights by drilling into evidence with more detail.
Due to the significant decline in smoking and an increase in advances for early cancer detection and screening, the cancer death rate has declined 27% in the United States from 1991 to 2016, according to the American Cancer Society’s annual report on cancer rates.
A look back at all the FDA news that happened in the month of December 2018, including several new approvals, an accelerated approval, and a priority review.
To assist clinicians in the day-to-day management of their patients, the Society for Immunotherapy of Cancer has developed its first guidelines to help direct immune checkpoint inhibitor treatment of NSCLC.
Adding aggressive, local radiation or surgery to frontline systemic therapy in patients with stage IV NSCLC whose disease has spread to a limited number of sites resulted in improved overall survival, according to findings presented by Daniel Gomez, MD, and colleagues at the 60th Annual Meeting of the American Society for Radiation Oncology in San Antonio, Texas.
The review period for a supplemental biologics license application for first-line treatment with pembrolizumab monotherapy for the treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with PD-L1 expression (tumor proportion score) of ≥1% and no <em>EGFR </em>or <em>ALK </em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck, the manufacturer of pembrolizumab.
Several oncology experts discuss the FDA approvals they found most significant in 2018.
Precision medicine has produced some dramatic successes in patients with advanced cancer. With developments in molecular profiling, targeted therapies are being applied to multiple tumors, most notably in advanced melanoma, NSCLC, and several types of leukemia. Alison Schram, MD, and David M. Hyman, MD, point out the challenges in determining the proportion of patients who will benefit from receiving targeted therapies.
Acquired resistance to tyrosine kinase inhibitors targeting <em>EGFR</em> mutations in patients with non–small cell lung cancer are leading to next-generation therapies equipped to circumvent the mutations that arise from initial treatment. A review of these mechanisms, and the latest agents being developed to address them, shows that the pipeline holds promise for the future.
The phase III TAHOE trial evaluating rovalpituzumab tesirine as a second-line treatment for patients with advanced small cell lung cancer has been put on hold, based on a recommendation from an Independent Data Monitoring Committee, according to AbbVie, the developer of the investigational antibody-drug conjugate.<br />
Atezolizumab (Tecentriq) has been approved by the FDA for use in combination with bevacizumab, carboplatin, and paclitaxel as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer. This indication excludes patients with <em>EGFR</em>/<em>ALK</em> aberrations.
Based on findings from the phase III IMpower133 study, a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) has been granted a priority review by the FDA for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.
A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.
During a <em>Targeted Oncology </em>case-based peer perspectives program, Benjamin P. Levy, MD, discussed his clinical considerations for the management of non–small cell lung cancer.
Complex drug trials that use a single protocol to test either 1 agent against multiple cancers or multiple agents against 1 cancer can make drug testing faster, cheaper, and more informative, particularly when those trials use the data to constantly improve protocols.
The CheckMate-451 trial missed its primary endpoint of overall survival with the combination of nivolumab and ipilimumab as a maintenance therapy for patients with extensive-stage small cell lung cancer without disease progression following frontline platinum-based chemotherapy.
During a <em>Targeted Oncology </em>case-based peer perspectives program, Ryan Gentzler, MD, reviewed with other physicians his clinical considerations for the management of non–small cell lung cancer.
Using durvalumab (Imfinzi) combined with tremelimumab for the frontline treatment of patients with metastatic non–small cell lung cancer did not result in a statistically significant improvement in overall survival compared to standard chemotherapy, according to a press release from AstraZeneca.
Alexander E. Drilon, MD, discusses developing markers in the non–small cell lung cancer paradigm.
Alectinib (Alecensa) was found to be superior to crizotinib (Xalkori) as frontline therapy in Asian patients with untreated <em>ALK</em>-positive advanced non–small cell lung cancer (NSCLC), according to findings reported at the 2018 ESMO Congress.
Gilberto Lopes, MD, discusses findings from the phase III KEYNOTE-042 trial and ongoing developments with immunotherapy in NSCLC.