Krazati Approved for KRASG12C-Mutated Locally Advanced or Metastatic NSCLC
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
Diagnosis & Disease Information
Tecentriq Approved for Unresectable or Metastatic Alveolar Soft Part Sarcoma
The approval was based on data from a phase 2 study that included 49 patients with unresectable or metastatic ASPS.
Investigational Therapy Gets Fast Track Status for Glioblastoma Multiforme
In preclinical studies, WP1122 has shown to increase cellular uptake of 2-DG, increase drug half-life, and increase the ability to cross the blood brain barrier.
Tecentriq Indication for Previously Untreated Advanced Bladder Cancer Withdrawn
The decision to withdraw the indication was made based on findings from the subsequent confirmatory phase 3 IMvigor130 trial.
Rezlidhia Approved for Relapsed/Refractory AML With IDH1 Mutation
Olutasidenib is a small-molecule inhibitor of mutated IDH1.
FDA Passes on Poziotinib for HER2 Exon 20 Insertion Mutation-Positive NSCLC
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
Epcoritamab Granted Priority Review for Relapsed/Refractory Large B-Cell Lymphoma
Epcoritamab is designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells.
FDA Approves Additional Dosing Schedule for Rylaze
The MWF dosing option was approved under the Real-Time Oncology Review program based on data from the intramuscular administration part of a phase 2/3 trial.
Zejula Use for Second-Line Maintenance Treatment Restricted
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer
The approval was based on data from the SORAYA trial.
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