Ibrutinib Attains Priority Status for New Drug Application


FDA Priority Status Ibrutinib 936563-96-1Exciting new was recently revealed from Pharmacyclics, when it was announced that the New Drug Application for Ibrutinib was placed on a priority basis by the FDA. This NDA for Ibrutinib is applicable in two different oncology indications. The first indication for Ibrutinib is for patients with mantle cell lymphoma (MCL) who have received prior treatment with other oncologic medications, which have failed to remediate the patient’s condition. The second indication is aimed at patients who have chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), and who have also received previous oncologic treatments without success.

54th American Society of Hematology Annual MeetingPatients suffering  from refractory mantle cell lymphoma have demonstrated significant success after being treated with Ibrutinib. A Phase 2 study that was presented at the 54th American Society of Hematology Annual Meeting and Exposition in December 2012 offered exciting data to prove the efficacy of Ibrutinib. Studies from the Phase 2 multicenter trial of Ibrutinib identified a staggering 70 percent response rate from patients with mantle cell lymphoma. The progression-free survival rates after treatments with Ibrutinib were excellent, with 68 percent of patients demonstrating an overall response rate after roughly nine months.  The dose given to patients in this Phase 2 study was 560 milligrams daily, for 28 day cycles. The cycles were repeated as needed for each individual patient, although most patients responded quickly and showed marked improvement within the first six to nine months. The rapid response time from patients after treatment with Ibrutinib, as well as the more tolerable side effects as compared to other chemotherapeutic treatments, makes Ibrutinib a worthy option for patients with mantle cell lymphoma. Adverse effects did occur for patients who were treated with Ibrutinib, but they were less toxic and damaging as compared to previous treatments the patients had undergone. Nausea, rashes, diarrhea and anemia topped the list of frustrating, but not intolerable side effects.

LGM Pharma offers the active pharmaceutical ingredient Ibrutinib, CAS# 936563-96-1, for R&D purposes. Clients can be assured of quality products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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