Boehringer readies first cancer drug Gilotrif for US launch

Boehringer Ingelheim will next week mark another milestone in its oncology ambitions when it launches its first cancer drug in the US.

Gilotrif (afatinib) received FDA approval in July to treat patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations.

The personalised cancer drug was approved alongside a companion diagnostic developed by Qiagen to detect the presence of EGFR mutations.

Boehringer plans to support the launch of Gilotrif with a “comprehensive patient support programme” of access and clinical support services, including financial support.

Gilotrif's passage through the FDA regulatory process was a relatively speedy one, with the drug granted priority review in January this year due to the urgent need for new treatments in NSCLC, which accounts for about 85 per cent of all lung cancers.

In Europe, where it is set to be branded as Giotrif, afatinib last month received the backing of EMA scientific advisors at the Committee for Healthcare and Medical Products, putting it on course for full approval by December.

The company is also investigating the drug in breast cancer and head and neck cancer, while elsewhere its oncology pipeline includes the angiogenesis inhibitor nintedanib, in phase III trials for NSCLC and ovarian cancer, and polo-like kinase 1 (Plk1) inhibitor volasertib, which is in phase II testing for acute myeloid leukaemia.