FDA Approvals

Jazz Pharmaceuticals Announces U.S. FDA Approval of ModeysoTM (dordaviprone, Jazz Pharmaceuticals)  as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma.

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Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.

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DATROWAY® (datopotamab deruxtecan-dlnk, Daiichi Sankyo) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFRmutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinumbased chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

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Coding and Reimbursement Updates

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Northern California Clinical Trials

UCSF Helen Diller Family Comprehensive Cancer Center

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ELEGANT Clinical Trial Overview

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