Boehringer Ingelheim last week reached a milestone in its oncology ambitions with the US approval of its personalised lung cancer drug afatinib.
The Food and Drug Administration (FDA) approved the drug, which will be branded as Gilotrif, to treat patients with metastatic non-small cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) gene mutation.
The green light means Gilotrif is Boehringer’s first cancer drug approved for marketing in the US, adding another therapy area to the company’s existing strong presence in COPD, anticoagulation, HIV and Parkinson’s disease, as well as its relatively recent venture into diabetes through its 2011 partnership with Lilly.
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 account for about 85 per cent of all lung cancers.
Roche and Astellas also received fast-track status in January for their cancer drug Tarceva to cover first-line treatment of NSCLC, receiving approval for this expanded indication in March.
Like Tarceva (erlotinib), Gilotrif is also an EGFR inhibitor and is only approved for use in patients with the EGFR gene mutation, which counts for about 10 per cent of people with NSCLC.
To ensure both drugs reach the necessary patients, the FDA approvals for Gilotrif and Tarceva also cover a companion diagnostic to help determine if a patient’s lung cancer cells express the EGFR mutations.
Tarceva was approved alongside Roche’s own the cobas EGFR Mutation Test, while Gilotif’s recommendation features alongside the FDA approval of the therascreen EGFR RGQ PCR Kit, manufactured by UK-based device company Qiagen.
“The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” said Dr Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
In Europe, afatinib is still under review following Boehringer’s submission for marketing approval in September 2012.
The company is also investigating the drug in breast cancer and head and neck cancer, while elsewhere in its oncology pipeline includes the angiogenesis inhibitor nintedanib, in phase III for NSCLC and ovarian cancer, and polo-like kinase 1 (Plk1) inhibitor volasertib which is in phase II testing for acute myeloid leukaemia.