Afatinib Approval for Lung Cancer Expanded by FDA


“The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor uncommon EGFR alterations in L861Q, G719X, and/or S768I.

“The FDA initially approved afatinib in 2013 for the treatment of patients with metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions. In 2016, the FDA expanded the indication to include patients with squamous histology following progression on a platinum-based chemotherapy.”

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Targetable Mutations in NSCLC: More Testing Needed!

Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.

However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…

FDA Grants Priority Review to Afatinib for NSCLC With Rare EGFR Mutations


“The FDA has granted a priority review to a supplemental new drug application (sNDA) for afatinib (Gilotrif) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

“Uncommon mutations such as these represent less than 10% of the EGFR mutations found in NSCLC patients, but are associated with poor prognosis and survival, Boehringer Ingelheim, the manufacturer of afatinib, noted in a press release.”

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EGFR-mutant NSCLC: Choice of First-Line Treatment May Get More Complicated

Medical guidelines for treatment of newly diagnosed non-small cell lung cancer (NSCLC) mandate upfront testing of tumor tissue for mutations in the EGFR gene (as well as ALK and ROS gene translocation). EGFR mutations are found in 10 to 15% of white patients, but in patients of East Asian origin such mutations are in encountered in approximately 48%. However, with new data and drugs entering the playing field, newly diagnosed patients’ treatment decisions could become more complex.

There is a good reason to test for EGFR mutations: the accumulated data show that, compared to first-line chemotherapy, treatment with drugs that inhibit the activity of EGFR in patients with activating EGFR mutations improves patients’ median progression-free survival (PFS) time from 4.6 to 6.9 months to 9.6 to 13.1 months, and has a higher objective response rate (ORR). Moreover, EGFR inhibitors are associated with a significantly lower incidence of adverse effects and better control of disease symptoms. Continue reading…

Lung Cancer Highlights from ASCO 2016

This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…

US Widens Use of Boehringer's Lung Cancer Drug Gilotrif


“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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CHMP Recommends Afatinib for Second-Line NSCLC

“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.

“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”

Afatinib Shows Clinical Benefit for Lung Cancer Patients with Brain Metastases

“Non-small cell lung cancer (NSCLC) patients with common epidermal growth factor (EGFR) mutations and brain metastases showed improved progression-free survival (PFS) and response from the EGFR tyrosine kinase inhibitor (TKI) afatinib compared to standard platinum doublet chemotherapy.

“More than 25% of with advanced NSCLC experience progression to the brain from their primary lung and this number increases to 44-63% for those NSCLC tumors driven by EGFR mutations. Prognosis is poor and typically ranges for 1-5 months for those with . EGFR TKIs are highly effective therapies for advanced NSCLC driven by EGFR mutations, especially the common mutations, exon 19 deletions and L858R point mutations. Even though there are a number of EGFR TKIs approved for first-line therapy of EGFR mutation positive NSCLC, there is a scarcity of prospective data for EGFR TKIs in patients with brain metastases.”

Afatinib a Better Choice for EGFR-Mutated Lung Cancer in First-Line Treatment

“Patients with EGFR-activating mutations in advanced lung cancer seem to benefit more from afatinib than gefitinib as first-line treatment, researchers report at the first ESMO Asia 2015 Congress in Singapore.

“In the global, randomised, open-label Phase IIb LUX-Lung 7 (LL7) trial, the irreversible ErbB family blocker afatinib significantly improved efficacy versus gefitinib across a range of clinically relevant endpoints, such as progression-free survival, time-to- failure and objective response rate. ‘Based on these results I would consider afatinib as the EGFR (TKI) of choice for the first-line treatment for patients with EGFR mutation-positive non-small-cell (NSCLC),’ lead author, Professor Keunchil Park, head of the Division of Hematology/Oncology at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, said.”