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Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1] [2] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.
Alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Nadofaragene firadenovec (Adstiladrin): treatment for bladder cancer [13] Obecabtagene autoleucel (Aucatzyl): treatment of acute lymphoblastic leukemia [14] [15] Onasemnogene abeparvovec (Zolgensma): AAV-based treatment for spinal muscular atrophy [16] Strimvelis: treatment for adenosine deaminase deficiency (ADA-SCID)
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
The approval was based on REVEL trial. [12] In April 2015, ramucirumab was approved by FDA for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and fluoropyrimidine.
In June 2018, it was approved for the treatment of certain melanomas by the U.S. Food and Drug Administration (FDA) in combination with encorafenib. [6] The FDA approved binimetinib based primarily on evidence from one clinical trial (NCT01909453) of 383 patients with BRAF V600 mutation-positive melanoma that was advanced or could not be ...