US regulators have decided to carry out a speedy review of Boehringer Ingelheim's afatinib, the firm's first oncology drug to be filed in the country.
The move means that the US Food and Drug Administration will make a decision on whether to approve afatinib - which also holds Orphan Drug status - for a small subset of lung cancer patients by the third quarter of this year.
Specifically, the company is seeking permission to market the drug for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation.
The filing is based on data from the LUX-Lung clinical trial program, including LUX-Lung 3, in which afatinib showed "unprecedented efficacy versus chemotherapy", the company previously noted.
The study pitted afatinib against the best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous NSCLC in patients with stage IIIb or IV adenocarcinoma of the lung and an EGFR mutation.
Progression-free survival benefit
Patients taking BI's drug as a first-line treatment surveyed for 11.1 months without their tumour progressing compared to 6.9 months for those taking the chemotherapy regimen, clearly demonstrating its potential benefit.
Data from the programme also underpinned the drug's filing in Europe in September last year.
"Based on the acceptance of the afatinib application, along with our developing oncology pipeline, we are moving forward with our plans to establish a world-class oncology commercial organisation," commented Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals.