Martin Wright, Regional Vice President, AstraZeneca Japan, said: “We are very excited by the positive data we have seen with IRESSA as the prognosis and treatment of lung cancer is poor and the symptoms extremely debilitating. If approved, IRESSA will offer patients a convenient once-daily oral therapy that is generally well tolerated, and can deliver fast and significant improvements in disease-related symptoms and disease control.”

Lung cancer is becoming more prevalent. The worldwide market for medicines to treat lung cancer is currently worth $1.6 billion, the majority of which is accounted for by NSCLC. In Japan, the MHLW is forecasting an 80 per cent increase in the incidence of lung cancer in the next 15 years.

The Japanese submission was based on data from two phase II trials involving over 400 patients worldwide, which demonstrated that IRESSA given as monotherapy, at a dose of 250 mg/day leads to objective response or disease stabilisation in many previously treated patients with advanced NSCLC.

In many patients, treatment with IRESSA also produced consistent and prolonged relief of disease-related symptoms including patient-reported shortness of breath, coughing and chest tightness.

In the majority, this improvement was reported within the first one to two weeks of treatment. Importantly, these benefits were achieved without the accompanying severe side effect burden typically seen with conventional cytotoxic chemotherapy used for NSCLC such as neutropenia, alopecia, neuropathy and severe nausea and vomiting. The most commonly seen side effects with IRESSA were mild skin reactions like rash, dry skin, acne or pruritus, and mild diarrhoea, which did not require prophylactic treatment during the study. Two large Phase III studies evaluating IRESSA as a potential first-line agent for NSCLC, in combination with commonly used chemotherapy combinations are currently ongoing.

IRESSA is the first in a new class of anti-cancer drugs known as small molecule, selective EGFR inhibitors. IRESSA has a mode of action distinct from cytotoxic chemotherapies, and is administered as a once daily, oral tablet.

IRESSA targets and blocks, within the cell, signalling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumours; therefore IRESSA may have therapeutic potential in a broad range of common cancers. IRESSA is in Phase II clinical trials in a variety of tumours including breast, colorectal, gastric and hormone refractory prostate cancers.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.