Boehringer Ingelheim announced that the European Commission has granted marketing authorization for afatinib monotherapy, for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). Afatinib will be marketed in Europe under the brand name Giotrif.
“We are delighted with the decision by the European Commission. We hope this will be the first of many registrations for drugs from our in-house oncology research program,” said Klaus Dugi, corporate senior vice president, Medicine, Boehringer Ingelheim. “The approval of afatinib in Europe reinforces our commitment to bringing the right treatments to the right patients. This is a significant step towards meeting the substantial unmet need in lung cancer treatment.”
Lung cancer is one of the most common forms of cancer, accounting for 1.6 million new cases each year. It is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined. In Europe alone, lung cancer is responsible for almost 270,000 deaths each year. Although incidence rates are higher in men than women it has been suggested that, by 2015, lung cancer will overtake breast cancer as the biggest cause of female cancer death in Europe.
Because lung cancer is more than one disease, distinct subtypes can be characterized by receptors that are frequently altered or overexpressed in cancer cells. One such molecular marker is EGFR (a member of the ErbB Family of receptors). The prevalence of tumors harboring EGFR mutations is between 10 to 15 percent in Caucasian and 40 percent in Asian NSCLC patients.
In clinical trials, afatinib has been shown to offer patients with this type of lung cancer a significant delay in tumor progression, coupled with improvements in their lung cancer related symptoms (e.g. shortness of breath, cough and chest pain) and quality of life. Therefore, early mutation testing for EGFR status is a crucial step in the treatment-decision pathway, to give patients the opportunity to receive the appropriate personalized therapy from the start.
“Its unique mode of action allows afatinib to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer,” said Dr. Sanjay Popat, consultant medical oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial. “Clinical data demonstrates afatinib’s efficacy in delaying tumor growth and improving lung cancer related symptoms, making it an important addition to our treatment options in Europe.”
Following recent approvals in the U.S., Taiwan and Mexico, European Union approval of afatinib is based on data from the pivotal LUX-Lung 3 trial and other Phase 3 and Phase 2 lung cancer studies. Data from Phase 3 LUX-Lung 3 trial have shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumor growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumors harboring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumor progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.
The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhea (14 percent), rash (16 percent), and inflammation of the nail bed (paronychia) (11 percent). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15 percent), fatigue (13 percent), and leucopenia (8 percent). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8 percent discontinuation rate for afatinib; 12 percent for chemotherapy). One percent of patients in the afatinib arm discontinued due to drug-related diarrhea.
Date: September 25, 2013
Source: Boehringer Ingelheim