Boehringer’s Gilotrif approved in US for lung cancer with non-resistant EGFRs
pharmafile | January 16, 2018 | News story | Manufacturing and Production, Sales and Marketing | Boehringer Ingelheim, Cancer, FDA, Giltrif, NSCLC, lung cancer
Boehringer Ingelheim is celebrating the FDA’s decision to expand the indication of its lung cancer drug Gilotrif (afatinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFRs).
The US regulator’s decision was based on positive trial data which included the investigation of patients with the EGFR mutations L861Q, G719X and S768I.
“Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” commented Edward S Kim, Chair of Solid Tumor Oncology and Investigational Therapeutics at Levine Cancer Institute of Carolinas HealthCare System. “The approval of Gilotrif as a targeted therapy for these additional nonresistant EGFR mutations significantly alters the treatment strategy for this population.”
The new indication adds to the areas in the US where Gilotrif is already approved: the first-line treatment of patients with NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, and the treatment of squamous cell carcinoma of the lung in patients whose disease has progressed following the administration of platinum-based chemotherapy.
Senior Vice President of Medicine and Regulatory Affairs at Boehringer Ingelheim, Sabine Luik, also remarked: “With this expanded indication for Gilotrif, NSCLC patients whose tumours have certain EGFR mutations now have an approved therapy that specifically targets these mutations. This approval is a result of our company’s commitment to delivering meaningful treatment advances in areas with high unmet medical need and reflects the tireless efforts of physicians, researchers and patients who participated in our studies.”
Matt Fellows
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