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The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications. Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.
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The first regulatory approval has been granted to entrectinib in Japan. The Japanese Ministry of Health, Labour and Welfare recently approved the agent for the treatment of adult and pediatric patients with <em>NTRK </em>fusion–positive, advanced recurrent solid tumors.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

Two abstracts presented at the 2019 ASCO Annual Meeting analyzed potential combinations with osimertinib (Tagrisso), a third-generation EGFR TKI, with additional agents to potentially overcome resistance mutations following progression in patients with <em>EGFR</em>-mutant NSCLC.

In an interview with <em>Targeted Oncology</em>, Kazuhiko Nakagawa, MD, PhD discussed the findings from the RELAY trial for the combination of ramucirumab plus erlotinib compared to erlotinib plus placebo. He suggested that these data could be practice-changing for the treatment of newly diagnosed patients with <em>EGFR</em>-positive NSCLC.<br />

Kartik Konduri, MD, discussed with a group of physicians in a recent <em>Targeted Oncology </em>live case-based peer perspectives presentation the diagnostic workup and treatment considerations he makes when he sees a patient with non–small cell lung cancer in the clinic. Konduri explained his treatment decision making based on the case scenario of a patient with locally advanced NSCLC.

An accelerated approval has been granted by the FDA to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population ≥10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.











































