FDA to Review Novel Regimen for Treating Metastatic Pancreatic Ductal Adenocarcinoma
The sNDA included 770 patients who have not previously received chemotherapy for mPDAC.
Diagnosis & Disease Information
The Alien Inside My Brain: Case Study on Glioblastoma Multiforme
Case study outlines the workup and treatment of glioblastoma multiforme, the most common malignant brain tumor.
Osemitamab Gets Orphan Drug Status for Pancreatic Cancer
Osemitamab is a high affinity, humanized antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-Claudin18.2 monoclonal antibody.
Lunsumio Approved for Relapsed or Refractory Follicular Lymphoma
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.
Brukinsa Gains Approval for Chronic Lymphocytic Leukemia
The approval was based on data from the phase 3 SEQUOIA and ALPINE studies in patients with CLL/SLL.
Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
Jaypirca Approved for Relapsed/Refractory Mantle Cell Lymphoma
As a noncovalent inhibitor of BTK, pirtobrutinib is able to reestablish BTK inhibition in patients previously treated with covalent BTK inhibitors.
Orserdu Approved for ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer
In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
Turalio Dosing Regimen Updated for Tenosynovial Giant Cell Tumor
A new dosing regimen for Turalio® (pexidartinib) is now available for the treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The recommended dose of Turalio is now 250mg orally twice daily (taken as two 125mg capsules) with a low-fat meal…
Jemperli Granted Full Approval for dMMR Recurrent or Advanced Endometrial Cancer
The conversion to regular approval was based on data from an additional 141 patients with dMMR recurrent or advanced endometrial cancer who had progressed on or after a platinum-containing regimen.
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