Boehringer celebrates FDA OK for lung cancer drug afatinib

The FDA has handed oncologists another weapon in the fight against lung cancer. The agency today approved Boehringer Ingelheim's afatinib, a targeted therapy for non-small cell lung cancer which will be tied to a diagnostic test to identify the portion of the late-stage patient population most likely to respond to the drug, which will be sold as Gilotrif.

Afatinib figured prominently at ASCO last year as Boehringer Ingelheim promoted its in-house development program. Patients taking the drug had an average rate of progression-free survival of 11.1 months compared to 6.9 months for the standard therapy arm. More impressively, patients with the two EGFR mutations studied survived 13.6 months without seeing their cancer get any worse.

The drug was approved concurrently with therascreen, a Qiagen ($QGEN) diagnostic used to identify patients whose lung cancer cells express EGFR. The drug is a tyrosine kinase inhibitor designed to coral proteins that drive cancer. It's most likely to work in patients whose tumors express EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. And that's the kind of patient targeting that the FDA has been encouraging.

"Today's approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations."

The first drug to be approved by the FDA was Astellas' Tarceva, which won the expanded OK back in May.

Lung cancer has proven to be a tough target for drug developers and the prognosis for survival is often quite poor. But there are other drugs in the pipeline that may be added to oncologists' weapon chest in the not too distant future. Two of those drugs--the next-gen ALK inhibitor LDK378 from Novartis and the immunotherapy nivolumab from Bristol-Myers Squibb ($BMY) --have both been designated as breakthrough drugs worthy of VIP treatment at the FDA.

The approval marks an important win for Boehringer Ingelheim, which has a pipeline of home grown cancer drugs in the pipeline. Last month it garnered attention for nintedanib--an angiogenesis inhibitor designed to eliminate the blood vessels that feed tumor growth. PFS was 3.4 months compared to 2.7 months in the docetaxel-only group of lung cancer patients. The median OS data, a secondary endpoint, was 10.1 months for nintedanib and 9.1 months for docetaxel, but significantly there was a 2.3 month advantage for patients with adenocarcinoma histology--reflecting a key advantage over the squamous cell group in the study.

- here's the release from the FDA
- here's FierceMedicalDevices' take on Qiagen's test

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