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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 ...
In October 2020, the U.S. FDA approved the combination of nivolumab with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. [32] This is the first drug regimen approved for mesothelioma in sixteen years and the second FDA-approved systemic therapy for mesothelioma. [32]
The approval allows the use of the cancer drug, Rybrevant, in combination with J&J's existing drug, lazertinib, as a first-line treatment for non-small cell lung cancer (NSCLC) patients with a ...
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. [ 5 ] [ 6 ] [ 11 ] [ 8 ] [ 12 ] Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, [ 6 ] and full approval in February 2023.
granted for three indications: HER2-positive breast cancer with prior anti-HER2-based treatment; HER2 low (IHC 1+ or IHC 2+/ISH) breast cancer; and non-small cell lung cancer with an activating HER2 mutation Dupilumab: Regeneron Pharmaceuticals: granted for two indications: eosinophilic esophagitis; and atopic dermatitis: Ivosidenib: Servier ...
A huge advancement in cancer treatment after the Food and Drug Administration just approved a type of cell therapy for patients with late-stage melanoma.
The U.S. Food and Drug Administration (FDA) has approved imatinib as first-line treatment for Philadelphia chromosome-positive CML, both in adults and children. The drug is approved in multiple contexts of Philadelphia chromosome-positive CML, including after stem cell transplant, in blast crisis, and newly diagnosed. [12]
In July 2014, the FDA granted breakthrough therapy status to blinatumomab for the treatment of acute lymphoblastic leukemia (ALL). [12] In October 2014, Amgen's Biologics License Application for blinatumomab was granted priority review designation by the FDA , thus establishing a deadline of 19 May 2015, for completion of the FDA review process.