Genentech, a member of the Roche Group, announced completing the submission of a supplemental Biologics License Application, or sBLA, to the FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer, or EBC, with residual disease after neoadjuvant treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
https://thefly.com/landingPageNews.php?id=2858815
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