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A look back at all the FDA news that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

In findings presented during the 2019 AACR Annual Meeting, safety and efficacy was seen with CAR T cells targeting mesothelin-expressing tumors in a preliminary clinical evaluation in patients with malignant pleural disease.

Lurbinectedin (PM1183) monotherapy induced responses in patients with relapsed small cell lung cancer, achieving the primary endpoint of overall response rate in a single-arm phase II trial, according to an announcement from PharmaMar, the company developing lurbinectedin.

The FDA has approved the combination of atezolizumab plus carboplatin and etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer.

Based on 2 case scenarios, H. Jack West, MD, discusses treatment options and the data that support these options for the management of squamous and nonsquamous non–small cell lung cancer.

The healthcare community is still awaiting a response from the Centers for Medicare & Medicaid Services to the opposition of the agency’s proposal to substantially revise the Medicare Part D protected drug classes.

During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Kartik Konduri, MD, recently discussed the treatment considerations and decisions he makes when treating patients with non–small cell lung cancer.

Robert L. Ferris, MD, PhD, Co-Physician Editor in Chief, <em>Targeted Therapies in Oncology</em>,<em> </em>discusses<em> </em>the<em> </em>evolving<em> </em>role of immunotherapy in melanoma and non–small cell lung cancer, where by it is now the dominant therapeutic approach in these diseases in progressively earlier lines of therapy.

Overtreating men 70 years or older with prostate cancer cost Medicare more than $1.2 billion from 2004 to 2007, according to the results of a retrospective study using the Surveillance, Epidemiology, and End Results–Medicare linked database.

Progression-free survival, the primary endpoint of the RELAY trial, was significantly improved with frontline ramucirumab in combination with erlotinib compared to placebo plus erlotinib in patients with metastatic <em>EGFR</em>-mutant non–small cell lung cancer.

Due to an active research landscape, the National Comprehensive Cancer Network Guidelines for non–small cell lung cancer have had 3 recent updates that include numerous clinically relevant recommendations.

Julie R. Brahmer, MD, discusses data for atezolizumab plus platinum/etoposide versus platinum/etoposide alone in patients with small cell lung cancer in the IMpower133 trial.

Edward B. Garon, MD, discusses the role of EGFR-targeted therapies in the treatment landscape of NSCLC.

A look back at all the FDA news in oncology from the month of February 2019, including several new approvals, priority review designations, and an orphan drug desgination.

Guardant360—a 73-gene next-generation sequencing panel—detected all of the guideline-recommended biomarkers in patients newly diagnosed with metastatic non–small cell lung cancer at a similar rate, but in a faster turnaround time than tissue genotyping, according to data from the NILE study.








Stage IIIB Unresectable NSCLC After Chemoradiotherapy






























