HSA approves lung cancer drug
The Singapore Health Sciences Authority (HSA) has approved the use of Giotrif® (afatinib) for the first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Lung cancer is the most commonly diagnosed cancer in the world, with 1.6 million new cancer cases annually. More than half of these lung cancer cases occur in Asia, which accounts for more than 14 percent of all cancers and over 18 percent of all cancer deaths in the region. Compared to other cancers, lung cancer has the highest death rate amongst men (27.6 percent) and the second highest mortality rate for women (16.7 percent).
Research has shown there are many different types of lung cancer, each requiring specific treatment approaches. One distinct subtype of lung cancer is defined by mutations in EGFR, which has an incidence rate that is three times higher in Asia than in Western countries.
In order to ensure that patients have the opportunity to receive the best personalized treatment from the start, physicians and oncologists recommend routine testing of genetic mutations in lung cancer cells, particularly for EGFR status.
“We are very delighted with the approval of Giotrif® as it means that patients with EGFR mutation positive NSCLC in Singapore can now benefit from this new targeted treatment option. This is a significant step for us in moving towards meeting the substantial unmet need in lung cancer treatment,” said Dr. Bernard Aubert, Head of Medical, Regional Operating Unit, SEA & South Korea, Boehringer Ingelheim.
The efficacy of Giotrif® is supported by recent data from two pivotal large-scale Phase III studies, the global LUX-Lung 3 trial and its companion LUX-Lung 6, which were conducted in China, Korea and Thailand. Together, they show that Giotrif® has superior efficacy and a manageable tolerability profile as compared to standard chemotherapies, making it an important choice for use as a first-line treatment for patients with EGFR mutation positive NSCLC.
The trials showed that patients treated with Giotrif® lived for almost a year before their tumor started to grow again versus just over half a year for those on chemotherapy. In addition, the delay in tumor progression was coupled with improvements in patients’ lung cancer related symptoms, such as shortness of breath, cough and chest pain.
The most common drug-related adverse events, diarrhea, rash and stomatitis, were noted to be manageable and reversible. Overall, patients in both studies also reported to have a significantly better quality of life, as measured by standard patient questionnaires.
Source: Asian Scientist
Published: 22 May 2014
Category: Features, Pharmaceuticals
