The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.
The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
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The Phase I study is testing a bispecific antibody, XmAb14045, in acute myeloid leukemia, under a partnership with Swiss drugmaker Novartis. Xencor's stock fell following the news.
5AM Ventures and RA Capital Management led the round. The company is developing hematopoietic stem cells engineered to be protected from targeted immunotherapies.
The drug offers greater convenience and efficacy than the old chemotherapy combination, but its high cost and first impressions among doctors may explain why Jazz had to lower its sales guidance.
The drug, combined with Celgene's Vidaza, Otsuka's Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.
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The drug is the second FLT3 inhibitor to win approval, after Novartis' Rydapt in first-line disease. Daiichi Sankyo's quizartinib could present competition if it wins approval, but it would target a somewhat narrower population of FLT3-mutated patients.
The approval is the latest of several drugs approved for the disease, a form of blood cancer, since last year.
Under the terms of the partnership between MEI Pharma and Helsinn, the latter will develop and market the former's cancer drug targeting acute myeloid leukemia.
Tolero Pharmaceuticals, a Salt Lake City, Utah drug developer, has set its sights on ramping up the commercialization and development efforts of its acute myeloid leukemia treatment, which will enter Phase 3 trial sometime next year. The company’s fresh off of closing a Series B round of $14.2 million, though the initial aim for the […]
Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.