FDA Grants Accelerated Approval to Ceritinib For ALK- Positive NSCLC


FDA Grants Accelerated Approval to Ceritinib CAS 1032900-25-6Phase 1 clinical trial results for Ceritinib have revealed affirmative results, leading the FDA to grant an accelerated approval for this impressive drug. Deemed to be “highly active” in the fight against ALK-rearranged non-small-cell lung cancer, Ceritinib is also twenty times more potent than Crizotinib.

The exciting results from Novartis’s Phase 1 trial were recently published in the New England Journal of Medicine, and two Phase ll trials as well as two Phase lll trials are underway and enrolling patients. The ability of Ceritinib as a novel anaplastic lymphoma kinase to pack a punch with unusual anti-tumor properties makes this phenomenal treatment one to watch. Should Ceritinib, also known as the brand name Zykadia, gain a first line indication from the FDA against non-small-cell lung cancer the possibility for billions of dollars in sales is quite real.

Results from the Ceritinib Phase l trial focused on 21 centers and 163 patients. The patients involved received 750 milligrams of Ceritinib once daily in 21 day cycles. Roughly 68 percent of these participants had been dosed with Crizotinib prior to this trial, and found that drug to be unsuccessful. However, Ceritinib proved worthy, showing an overall response rate of 58 percent in clinical trial participants. A progression-free survival rate of 7 months was outstanding for this patient group, considering their prior resistance to sister drug Crizotinib.

Approximately 5 to 7 percent of patients with non-small-cell lung cancer {NSCLC}, or almost 100,00 patients possess the ALK gene mutation, rendering current best in care treatment, like Crizotinib, limited success. The FDA granted an accelerated approval of Ceritinib on April 29, 2014 for patients with ALK-positive NSCLC that is unresectable and unresponsive to previous treatment with Crizotinib. The recommended dosage of Ceritinib is 750 milligrams one time daily, as five 150 milligram capsules, on an empty stomach. Adverse effects included nausea, gastrointestinal issues and anemia.

LGM Pharma provides the Ceritinib, CAS# 1032900-25-6 API for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

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