Novartis is celebrating after getting the green light from regulators in the USA four months earlier than expected for its metastatic lung cancer treatment Zykadia.

The Food and Drug Administration has granted accelerated approval to Zykadia (ceritinib) for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib). The approval is based on a trial that included 163 patients with metastatic ALK+ NSCLC who were previously treated with Xalkori and Zykadia achieved an overall response rate (tumour shrinkage) of 54.6% and a median duration of response of 7.4 months.

Zykadia, previously known as LDK378, is the fourth medicine to be approved following FDA breakthrough therapy designation, which was received in March last year. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said the decision demonstrates the agency's "commitment to working cooperatively with companies to expedite a drug’s development, review and approval".

The thumbs-up came well ahead of the product’s prescription drug user fee goal date of August 24. Novartis oncology chief Alessandro Riva said that the approval of Zykadia "less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly-focused approach to drug development and strong collaboration".