Pfizer Inc. announced that the European Medicines Agency (EMA) has accepted Pfizer’s regulatory submissions for review of two investigational compounds - crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of patients with previously treated ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC); and bosutinib for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukaemia (CML) in the chronic phase.

“With the EMA submissions for crizotinib and bosutinib, we are one step closer to potentially bringing two promising agents to patient populations in areas of significant unmet medical need,” said Dr Andreas Penk, president of Pfizer Oncology Europe. “These filings underscore Pfizer’s commitment to delivering innovative therapeutic treatment options targeting various tumour types and improving the outcome for cancer patients worldwide.”

In clinical trials of crizotinib, patients were prospectively screened for the ALK gene alteration, indicating their likelihood to respond to the treatment. By inhibiting ALK, crizotinib blocks signalling in a number of cell pathways that are believed to be critical for the growth and survival of tumour cells. Preliminary epidemiology suggests that approximately 3-5 per cent of NSCLC tumours are ALK-positive.

Crizotinib is being further evaluated in two randomized phase III trials in patients with ALK-positive NSCLC: PROFILE 1007 and PROFILE 1014 will compare the safety and efficacy of crizotinib to standard-of-care chemotherapy as a first-line and second-line therapy, respectively.

Worldwide, lung cancer is the leading cause of cancer death in both men and women. In Europe, lung cancer accounts for 20 per cent of all cancer-related deaths. NSCLC accounts for about 85 per cent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting. Approximately 75 per cent of NSCLC patients are diagnosed late with metastatic, or advanced, disease, where the five-year survival rate is only 6 per cent. In addition, the current standard of care for patients with advanced NSCLC demonstrates a response rate of about 9-35 per cent.

Bosutinib is an investigational oral dual Src and Abl kinase inhibitor with minimal inhibitory activity against c-kit and PDGFR. It is believed that by dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.

CML, one of the four main types of leukaemia, accounts for 15 per cent of all leukaemias worldwide. A hallmark of CML is an abnormal chromosome known as the Philadelphia Chromosome, a DNA mutation that initiates a series of events leading to the development of Bcr-Abl, a tyrosine kinase that causes CML cells to grow and reproduce rapidly.

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. It focussed on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers.

Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals.