FDA approves Boehringer’s lung cancer drug
pharmafile | July 12, 2013 | News story | Medical Communications, Sales and Marketing | Boehringer, FDA, Roche, Tarceva, afatinib, lung cancer
Boehringer Ingelheim’s late-stage lung cancer drug Gilotrif has received an accelerated FDA approval for patients with a certain genetic mutation.
Gilotrif (afatinib) can now be used in the US for patients with late stage non-small cell lung cancer (NSCLC), whose tumours express specific types of EGFR gene mutations.
The drug has been given a priority review by the regulator, speeding up the overall approval process.This is also BI’s first oncology medicine to approved in any market.
To establish which patients will be able to be treated by the drug, the FDA has also simultaneously approved Qiagen’s therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.
“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, director of the office of haematology and oncology products at the FDA.
Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumours harboured EGFR mutations.
Participants receiving Gilotrif had a delay in progression-free survival that was 4.2 months later than those receiving chemotherapy. There was, however, no statistically significant difference in overall survival, the golden standard in oncology trials.
“We are delighted to announce the first approval of afatinib, offering a new personalised treatment approach for patients with EGFR mutation positive NSCLC,” said Prof Klaus Dugi, corporate senior VP of medicine at Boehringer.
“It marks the first of what we hope will be many products to emerge from our oncology research and development programme, and underscores our continued commitment to translating innovative science into new treatment options for patients,” Prof Dugi added.
The drug will compete with Roche’s cancer pill Tarceva, which in May was approved by the FDA for first-line treatment of patients with NSCLC.
As a second, third and a maintenance therapy for the disease, the drug generated over $1.4 billion in 2012 sales for the Swiss firm.
Tarceva also comes with a companion diagnostic, called the cobas EGFR Mutation Test, which is developed by Roche’s medical devices unit.
But Gilotrif represents an advance over its ‘first generation’ EGFR rival in that it blocks a wider range of targets, and is the first irreversible blocker.
This means that BI’s drug could also be given to patients who develop a ‘resistance’ to the first generation EGFR blockers, a common problem with personalised medicines.
Lung cancer is the leading cause of cancer-related death among men and women. According to the National Cancer Institute, an estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease this year.
About 85% of lung cancers are NSCLC, making it the most common type of lung cancer. EGFR gene mutations are present in about 10% of NSCLC.
Ben Adams
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