FDA to Review Novel Regimen for Treating Metastatic Pancreatic Ductal Adenocarcinoma
The sNDA included 770 patients who have not previously received chemotherapy for mPDAC.
The sNDA included 770 patients who have not previously received chemotherapy for mPDAC.
Case study outlines the workup and treatment of glioblastoma multiforme, the most common malignant brain tumor.
Osemitamab is a high affinity, humanized antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-Claudin18.2 monoclonal antibody.
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.
The approval was based on data from the phase 3 SEQUOIA and ALPINE studies in patients with CLL/SLL.
The approval was based on data from the KEYNOTE-091 trial.
As a noncovalent inhibitor of BTK, pirtobrutinib is able to reestablish BTK inhibition in patients previously treated with covalent BTK inhibitors.
In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
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…
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.