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The FDA granted Breakthrough Therapy designation to JNJ-61186372 for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.
The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.
As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.
Julie R. Brahmer, MD, discusses the role of molecular testing for patients with lung cancer and why this is particularly important for those with early-stage disease.
Changes in the tumor microenvironment following progression on EGFR tyrosine kinase inhibitor therapy suggest a potential for benefit from PD-1/PD-L1 inhibitors in patients with EGFR-positive non–small cell lung cancer, according to the results of a retrospective study published in Clinical Cancer Research.
In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.
A 60-Year Old Man With Untreated Stage IV EGFR-Mutated Non-Small Cell Lung Cancer
High volumes of mutations observed through liquid biopsies may be associated with an improvement in progression-free survival and clinical benefit after first-line standard-of-care pembrolizumab-based therapy in patients with metastatic non-small cell lung cancer, according to findings from a prospective biomarker trial conducted by investigators at the University of Pennsylvania Perelman School of Medicine and Abramson Cancer Center, which were published in Clinical Cancer Research.
In an interview with Targeted Oncology, Zofia Piotrowska, MD, MHS, discussed the role of EGFR inhibition as frontline treatment of patients with EGFR-mutant lung cancers, as well as the combinations with osimertinib that are currently underway and appearing promising for this treatment landscape.
The FDA Oncologic Drugs Advisory Committee agreed that ramucirumab plus erlotinib showed a favorable benefit/risk profile in patients with untreated metastatic EGFR-positive non–small cell lung cancer in the phase III RELAY study. The vote was 6 to 5 in favor of the combination and ODAC has scheduled a hearing to discuss the terms of the Biologic License Application.<br />
In a <em>Targeted Oncology</em>™ case-based peer perspective live discussion, Sandip P. Patel, MD, associate professor of medicine at the University of California San Diego Health, discussed EGFR inhibition options for patients with non–small cell lung cancer, based on the case of a real patient.
To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.
The FDA has granted Priority Review to the New Drug Application for brigatinib as first-line treatment for patients with ALK-positive metastatic non–small cell lung cancer as detected by an FDA-approved test, Takeda Pharmaceutical Company announced in a press release.
Preliminary results from a safety and tolerability phase I/II study signal promise for ADXS-503 alone and in combination with pembrolizumab as treatment of patients with metastatic squamous and non-squamous non–small cell lung cancer, Advaxis, Inc, announced in a press release. Findings were presented during the International Association for the Study of Lung Cancer 2020 Targeted Therapies of Lung Cancer Meeting, February 19-22, 2020, in Santa Monica, California.
As one of the main challenges faced by cli­nicians who treat non small cell lung cancer, drug resistance continues to thwart efforts to mitigate disease progression. This is especially true for the class of drugs called tyrosine kinase inhibitors, which inhibit adenosine triphosphate at the binding site of tyrosine kinase.
The FDA has granted Priority Review to the supplemental Biologic License Application for atezolizumab as first-line treatment of patients with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The FDA has granted Priority Review to the New Drug Application for lurbinectedin, which is being considered for accelerated approval as a treatment of patients with small cell lung cancer who have progressed after prior platinum-containing therapy.
Zofia Piotrowska, MD, MHS, discusses the data from the randomized phase III FLAURA trial, which led to the widespread use of frontline osimertinib for the treatment of EGFR-mutant lung cancers.