The early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states. Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[…]
Early EU Approval for Ibrutinib
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, EU Approved 2014, FDA Priority Status Tags: CLLEUIbrutinib Oct 21, 2014
Idelalisib EU Approval Granted For Treating CLL and FL Patients
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014 Tags: chronic lymphocytic leukemiaCLLIdelalisibRituximab Sep 24, 2014
Gilead Sciences has been granted marketing authorization by the European Commission for its Idelalisib 150mg tablets (to be marketed as Zydelig) to treat the two incurable blood cancers Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL). This formidable first-in-class oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, plays a key role in the activation, proliferation and[…]
Idelalisib Is a Leader in Oncology Treatment
Chemotherapeutic / Anti-Neoplastic, NDA Tags: chronic lymphocytic leukemiaCLLIdelalisibRituximab Jun 18, 2014
Idelalisib has captured the attention of pharmaceutical research and development teams with the latest data touting its targeted treatment for both unresectable non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The FDA accepted Gilead Sciences’ new drug application early in 2014 for the treatment of refractory indolent NHL, and the target review date for the[…]
Ibrutinib Attains Priority Status for New Drug Application
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Priority Status Tags: chronic lymphocytic leukemiaCLLIbrutinibmantle cell lymphoma Sep 11, 2013
Exciting 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[…]
Will Ibrutinib be the Next Major Breakthrough in Cancer Treatment?
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API Tags: chemotherapychronic lymphocytic leukemiaCLLIbrutinib Jun 25, 2013
Ibrutinib was a shining star in the pharmaceutical headlines on June 20, 2013, with the news that this experimental drug used to treat chronic lymphocytic leukemia may be the next breakthrough cancer treatment. As a medication Ibrutinib is different from the usual chemotherapy treatments in that it pointedly targets specific processes, and prevents tumor proliferation.[…]
