Afatinib Granted Priority Review for Uncommon EGFR Mutations in Lung Cancer

Boehringer Ingelheim announced that the supplemental new drug application (sNDA) for afatinib (Gilotrif) has been granted priority review by the FDA, according to a press release.
The application for afatinib is being reviewed as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have an epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X, or S768I substitution mutations, according to Boehringer.
The submission was based on positive findings from a meta-analysis of studies from the LUX-Lung clinical trial program. These clinical trials explored the efficacy of afatinib in patients whose tumors have these uncommon EGFR mutations. 
Investigators evaluated objective response, disease control, duration of response, progression-free survival, and overall survival.
Uncommon EGRF mutations—including L861Q, G719X, or S7681—account for less than 10% of EGFR mutations in NSCLC and are linked to poor prognosis and survival, according to the release.
Afatinib was previously approved in the United States and the European Union as a first-line therapy for patients with NSCLC with EGFR exon 19 deletions or exon 21 mutations or for patients with squamous cell carcinoma of the lung whose disease progressed after platinum-based chemotherapy, according to the release.
The most common side effects include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, and itching. Boehringer also advises that afatinib can cause serious side effects, including diarrhea, skin reactions, lung or breathing problems, liver problems, eye problems, or heart problems.
“The acceptance of the sNDA filing with priority review recognizes our company’s ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options,” said Martina Flammer, MD, vice president, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Most Popular

Related Articles

Enzalutamide (Xtandi) is the first and only FDA-approved oral medication for both non-metastatic and metastatic castration-resistant prostate cancer.
Top news of the week from Specialty Pharmacy Times.
A look at last week's top stories in the world of pharmacy.
Company Profile >
Contributors >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2018
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.