The FDA granted accelerated approval to the first-in-class HER2-directed bispecific antibody zanidatamab-hrii. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic human epidermal...
The FDA Project Renewal initiative has updated the approved indications for fludarabine phosphate chemotherapy in chronic lymphocytic leukemia. The U.S. Food and Drug Administration (FDA) has approved updated labeling of fludarabine phosphate (Fludarabine Phosphate...
The FDA approved revumenib, a first-in-class menin inhibitor, to treat acute leukemias with a KMT2A translocation. The U.S. Food and Drug Administration (FDA) has approved revumenib (Revuforj) for the treatment of adult and pediatric...
The cell-based immunotherapy was approved for adults with relapsed or refractory acute lymphoblastic leukemia. The U.S. Food and Drug Administration (FDA) has approved obecabtagene autoleucel (Aucatzyl) for the treatment of adults with relapsed or...
The therapeutic was approved for certain patients with Philadelphia chromosome-positive chronic myeloid leukemia. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to asciminib (Scemblix) for adults with newly diagnosed, Philadelphia chromosome (Ph)-positive...
The FDA approved the claudin 18.2-targeted therapy Zolbetuximab-clzb for some gastric and gastroesophageal junction cancers. The U.S. Food and Drug Administration (FDA) has approved zolbetuximab-clzb (Vyloy) plus a chemotherapy regimen consisting of fluoropyrimidine- and platinum-containing...
The PI3K inhibitor is approved as part of combination therapy for certain patients whose breast cancer recurred on or after endocrine therapy. The U.S. Food and Drug Administration (FDA) approved inavolisib (Itovebi), in combination...
The immunotherapy is now approved to treat certain lung cancers before and after surgery. The U.S. Food and Drug Administration (FDA) has approved neoadjuvant nivolumab (Opdivo) with platinum-containing chemotherapy, followed by adjuvant nivolumab alone,...
The accelerated approval of selpercatinib for certain patients with thyroid cancer was converted to a full approval. The U.S. Food and Drug Administration (FDA) has granted full approval to selpercatinib (Retevmo) for patients 2...
The EGFR inhibitor osimertinib is now available as a monotherapy for certain patients with locally advanced, unresectable non-small cell lung cancer. The U.S. Food and Drug Administration (FDA) has approved osimertinib (Tagrisso) to treat...
AACR Fellow Lewis C. Cantley, PhD, leads a national effort targeting triple-negative breast cancer and ovarian cancer with a novel drug combination.
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