Tuesday, October 30, 2018 – Today the Food and Drug Administration (FDA) approved immunotherapy drug, pembrolizumab, also known as KEYTRUDA, in combination with chemotherapies, carboplatin, and either paclitaxel or nab-paclitaxel as a first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC). The results of the randomized trial showed an increase in overall survival, progression-free survival and overall response rate. Click here to read the full press release.
Friday, September 28, 2018 – Today the Food and Drug Administration approved VIZIMPRO tablets (dacomitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with an EGFR (epidermal growth factor receptor) mutation. Approval was based on a randomized trial that showed a significant improvement in progression-free survival for patients who received VIZIMPRO compared to the standard-of-care treatment. VIZIMPRO, an EGFR inhibitor targeted therapy, is an oral drug that is taken once a day. The following treatments [...]
Tuesday, January 16, 2018 – The FDA expanded approval of Gilotrif (afatinib), a first-line treatment for patients with non-small cell lung carcinoma (NSCLC) that is epidermal growth factor receptor (EGFR) mutation-positive. Patients with lung cancers with EGFR S768I, L861Q and G719X may now take Gilotrif. Gilotrif, an oral, once-daily EGFR-directed therapy developed by Boehringer Ingelheim, is currently approved in the U.S. to treat people with NSCLC that has certain EGFR gene changes, has spread to other parts of the body [...]
By Jennifer C. King, PhD, Director of Science & Research at Lung Cancer Alliance Research on the treatment of lung cancer has been moving quickly and 2017 was no different. Precision medicine was a key theme this year - there have been many treatment advances that depend on the gene changes in each person’s lung cancer. Approvals of New Drugs and Molecular Tests The United States Food and Drug Administration (FDA) has approved brand new drugs for non-small cell lung [...]
Monday, November 6, 2017 - The United States Food and Drug Administration (FDA) approved Alecensa (alectinib) as a first treatment for advanced non-small cell lung cancer that is positive for a biomarker called ALK. Alecensa was already approved for ALK+ lung cancer that was resistant to other ALK-targeted therapies. Now, a large randomized clinical trial showed that Alecensa was more effective than previous first-line treatment. Patients had an average of 25.7 months without their cancer progressing (getting worse) when taking [...]