AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US

Shots:

  • The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA
  • The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements
  • In May’2017, Imfinzi has received accelerated approval in the US based on Study 1108 while the continued approval was contingent on results from the P-III DANUBE study in the 1L metastatic bladder cancer setting, which did not meet its 1EPs in 2020

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Healthline

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AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Shots:

  • The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment
  • Result: The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target PGAR @26wks. of administration (54.5%)
  • The indication marks Humira’s 12th indication in Japan and making it the world’s first drug indicated for the treatment of PG. Humira has received MHLW’s ODD for the treatment of PG in 2019

Click here ­to­ read full press release/ article | Ref: Eisai | Image: Owned

The post AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum first appeared on PharmaShots.