Pfizer is celebrating after US regulators gave the green light to the first new drug for lung cancer in more than six years, a month earlier than expected.
The US Food and Drug Administration has approved Xalkori (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with late-stage non-small cell lung cancer. The agency has also approved a companion diagnostic test made by Abbott that will help determine if a patient has the abnormal ALK gene. About 1%-7% of those with NSCLC have the ALK gene abnormality and patients with this form of lung cancer are typically non-smokers.
Xalkori’s safety and effectiveness were established in two single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC, most of whom had received prior chemotherapy. In the studies, the objective response rate were 50% and 61%.
Xalkori is being approved under the FDA’s accelerated approval programme, so Pfizer will carry out further studies to confirm the drug’s clinical benefit. The company's head of oncology, Mace Rothenberg, said the treatment "represents a new chapter in personalised therapy for lung cancer, enabling physicians to provide the right treatment for the right patient”.
He added that the development of Xalkori, "from publication of the discovery of the ALK fusion gene in NSCLC to FDA approval in just four years, is a remarkable feat in the oncology world and reinforces the importance of collaboration among academic research, pharmaceutical, diagnostic and regulatory organisations". The company also quoted the University of Colorado's Paul Bunn as saying that Xalkori "represents a paradigm shift in NSCLC treatment, where we’re moving away from a one-size-fits-all approach to biomarker-based treatment decisions".
New Drug Applications for crizotinib have also been filed in the European Union, Switzerland, Japan and Korea.