publication date: May. 9, 2014

Drug Approvals

Accelerated Approval Granted To Zykadia in ALK+ NSCLC

FDA granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of metastatic non-small cell lung cancer.

Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval. It is being approved four months ahead of the product’s goal date of Aug. 24. The FDA had also granted Zykadia priority review and orphan product designations.

Zykadia is an anaplastic lymphoma kinase tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. Only 2 to 7 percent of patients with NSCLC are ALK-positive.

Zykadia’s safety and effectiveness were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. All participants were treated with Zykadia. Results showed that about half of the participants had their tumors shrink, and this effect lasted an average of about seven months.

Common side effects of Zykadia include gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain. Laboratory abnormalities such as increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed.

Zykadia is marketed by Novartis. The FDA’s accelerated approval program allows approval of a drug to treat a serious disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising drugs while the company conducts confirmatory clinical trials.


FDA granted orphan drug designation to ADXS-HPV for the treatment … Continue reading 40-19 Drug Approvals

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