Remove tag single-arm-trials
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TG Therapeutics challenges Roche with FDA filing for CLL drug

pharmaphorum

Aside from Gazyvaro, CLL can be treated with older chemotherapy agents, or Roche/AbbVie’s Venclexta (venetoclax) in some instances, and the fast track tag showed the FDA considered the combination to be a promising new contender on the market. TG said it expects the data submission to be complete in the first half of 2021.

FDA 52
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CHMP backs J&J’s myeloma CAR-T therapy Carvykti

pharmaphorum

Carvykti – developed by J&J with China’s Legend Biotech – was approved on the back of a single arm, open-label, clinical trial in 113 patients – CARTITUDE-1 – which showed an overall response rate of 84%, with signs of the cancer disappearing altogether in 69% of recipients.