Pfizer’s One of a Kind Genetic Lung Cancer Therapy Receives EU Conditional Approval
Pfizer’s recent lung cancer therapy targeting a specific genetic protein is the first personalized treatment of its kind to be approved by Europe.
Xalkori (crizotinib), the first personalized treatment for previously treated advanced non-small cell lung cancer (NSCLC), was launched by Pfizer in the UK. The drug was granted a conditional license by Europe for NSCLC patients whose tumors test positively for a specific protein known as ALK 1. Patients can only be eligible for the drug if they have tested positive for ALK by an accurate test undertaken by trained technicians. The conditional license for crizotinib was achieved due to data from two multi-center studies which included a Phase 2 study and a Part 2 expansion cohort of a Phase I study. This drug was already approved in the US in August 2011.
Pfizer will submit their findings from a confirmatory Phase 3 trial to European regulators at the EMA in the hope of getting a normal license for the treatment. The initial phase 3 study was presented at the European Society for Medical Oncology’s (ESMO) 2012 annual congress. Its findings demonstrate that crizotinib gave a better tumor response, progression-free survival and quality life as compared to the traditional practice of single line single agent chemotherapy.
For instance, the progression-free survival rate was doubled from a median of 3.0 months for patients using chemotherapy to 7.7 months for patients using crizotinib. This new therapy inhibits the ALK fusion protein meaning that the signaling in cell pathways responsible for the growth and survival of cancer cells is blocked.
Lung cancer currently accounts for more than a fifth of deaths in the UK making it the most common form of cancer in the country. There are about 85% NSCLC cancer cases which is often difficult to treat. 75% of NSCLC patients are diagnosed with metastatic disease (the advanced form of cancer), where the five year survival rate is only 1 – 5 %.
Pfizer is still working with Roche subsidiary Ventana Medical Systems and Cell Signaling Technology to develop its own diagnostic tool for Xalkori. The drug will still undergo a cost and clinical effectiveness review in 2013 by the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC).
Medical Director at Pfizer Oncology UK Dr. David Montgomery said: “Today's news is a significant milestone for people with ALK-positive advanced NSCLC in the UK. Crizotinib is a new personalized treatment which offers the hope of better outcomes for people with this kind of lung cancer. It demonstrates Pfizer's commitment to advancing the understanding of the underlying genetic drivers of diseases to help us to better identify people who are most likely to benefit from our treatments.”