![]() ZUMA-5 study is evaluating axicabtagene ciloleucel in patients with indolent NHL. These include a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) – ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL. Meanwhile, other studies with axicabtagene ciloleucel are also advancing. In Europe, a regulatory application was filed last week. Kite Pharma is looking to get axicabtagene ciloleucel approved for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications.Īxicabtagene ciloleucel is expected to be approved and launched in 2017. All these are types of aggressive non-Hodgkin’s lymphoma (NHL). The Biologics License Application (BLA) filing was based on data from a phase I-II study (ZUMA-1) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). for treating aggressive non-Hodgkin lymphoma (NHL) with a FDA decision expected on Nov 29. Kite Pharma’s lead drug axicabtagene ciloleucel is currently under priority review in the U.S. With no approved products in its portfolio, investor focus will primarily be on Kite Pharma’s cash burn and pipeline updates. Let’s see how things are shaping up for this announcement. It delivered positive earnings surprises in two of the past four quarters and negative surprise in the other two, bringing the average surprise to a positive 2.07%. ![]() The company has a mixed record of earnings surprises. ![]()
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