The MHLW has approved Calquence for treatment-naïve CLL incl. SLL. The approval was based on the results from the 2 clinical trials, incl. the P-III trial (ELEVATE-TN) evaluating Calquence (100mg, BID) as monotx. or in combination with obinutuzumab vs chlorambucil + obinutuzumab in a ratio (1:1:1) in 535 adult patients
The results showed PFS benefits, and a safety & tolerability profile consistent with the known profile for Calquence, 89% reduction in risk of disease progression or death in the combination therapy, and 79% as a monotx. at a median follow-up of 58.2mos.
The therapy was approved in the US for CLL & SLL while in the EU for CLL along with multiple other countries globally. The therapy was also approved in the US & other countries for MCL
Ref: AstraZeneca | Image: AstraZeneca
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