logo
Plus   Neg
Share
Email

CTI To Withdraw European Marketing Authorization Application For Pacritinib

CTI BioPharma Corp. (CTIC) announced the company will withdraw its European Marketing Authorization Application for pacritinib as a treatment for myelofibrosis. The CHMP was likely to formally adopt a negative opinion in its evaluation of the application, CTI stated. The CHMP indicated that the risk-benefit profile for pacritinib for the intended indication has not been sufficiently established with the clinical data available to date.

The company said it is continuing to develop pacritinib for both U.S. and European registration as a treatment for myelofibrosis patients with severe thrombocytopenia. CTI plans to seek scientific guidance from the EMA before beginning the planned Phase 3 study.

CTI BioPharma announced that on January 23, 2019, a planned third interim review of the PAC203 study was held by the Independent Data Monitoring Committee and the study will continue as scheduled.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss engineering major ABB Ltd. teamed with Italian utility Evolvere to launch a blockchain pilot project to explore transparent, secure peer-to-peer solar energy transactions, media outlet PV Tech reported. The companies will test the potential of blockchain technology in solar systems. The blockchain technology was developed in partnership with Prosume. Shares of Tesla Inc. are losing more than 5 percent in Monday's trading after Wedbush Securities analyst Daniel Ives slashed his price target on the luxury electric car maker's stock, citing "major concerns" around the trajectory of Tesla's growth prospects. In a note to investors, Ives also said he has concerns over underlying demand for Model 3 cars in the U.S. over the coming quarters. Amazon Inc. is leading a new $575 million investment in British food delivery company Deliveroo, intensifying the e-commerce giant's competition with rival Uber and its Uber Eats service. Deliveroo noted that Amazon is set to be the largest investor in the Series G preferred shared funding round. With the latest funding round, Deliveroo has raised $1.53 billion.
Follow RTT