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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 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 review period for&nbsp;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&ndash;small cell lung cancer with PD-L1 expression (tumor proportion score) of &ge;1% and no&nbsp;<em>EGFR&nbsp;</em>or&nbsp;<em>ALK&nbsp;</em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck,&nbsp;the manufacturer of pembrolizumab.

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&ndash;small cell lung cancer are leading to next-generation therapies equipped to circumvent the mutations that arise from initial treatment.&nbsp;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&nbsp;patients with advanced small cell lung cancer has been put on hold, based on a recommendation from an&nbsp;Independent Data Monitoring Committee, according to AbbVie, the developer of the investigational antibody-drug conjugate.<br /> &nbsp;