In June, the FDA's cancer drug update.
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Last Update: 2020-07-17
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Source: Internet
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Author: User
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Margetuximab has been awarded the title of orphan drug by FDA for the treatment of patients with gastric and gastroesophageal junction cancer.on June 05, FDA approved nivolumab (opdivo) for unresectable patients with advanced recurrent or metastatic esophageal squamous cell carcinoma who previously received fluorouracil and platinum based chemotherapy.on June 11, FDA awarded the title of orphan drug berubicin, an anthracycline anticancer drug, for the treatment of malignant glioma.FDA awarded dkn-01 orphan drug for the treatment of patients with gastric and gastroesophageal junction cancer.on June 12, oncomine precision detection was awarded the FDA's breakthrough treatment title, which was used to detect patients with low-grade gliomas with isocitrate dehydrogenase 1 and 2 mutations who may be in line with the treatment of IDH1 / idh2 inhibitor vorasidenib (ag-881).FDA approved the extended indications for Gardasil 9 to prevent oropharyngeal cancer and other head and neck cancer caused by HPV 16, 18, 31, 33, 45, 52 and 58.on June 15, the FDA approved the expansion of the indications of gittuzumab zogamicin (Mylotarg) to include pediatric patients with newly diagnosed CD33 positive acute myeloid leukemia, including 1-month-old infants.on June 16, FDA awarded liposome irinotecan (onivyde) fast track for the treatment of untreated and unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.FDA has approved the use of foundationone CDX as an adjunct diagnostic tool for keytruda to identify patients with solid tumors with a high burden of tumor mutation who will benefit from immunotherapy.on June 17, FDA awarded fruquitinib (frutiga) fast track for the treatment of Ras wild-type metastatic colorectal cancer patients who have received chemotherapy based on fluorouracil, oxaliplatin and irinotecan, anti VEGF therapy and anti EGFR treatment.on June 18, FDA awarded the relagolix priority review title for the treatment of patients with advanced prostate cancer.the FDA's target action date is December 20, 2020.FDA has accelerated the approval of selinexor for adult patients with recurrent or refractory diffuse large B-cell lymphoma (n.o.s.) who have received more than two systemic treatments.indications include patients with diffuse large B-cell lymphoma caused by follicular lymphoma.on June 22, FDA approved pembrolizu mAb for the treatment of patients with recurrent or metastatic skin squamous cell carcinoma that cannot be cured by surgery or radiotherapy.on June 24, the FDA granted lilotomab satetraxetan fast track designation for the treatment of adult patients with recurrent or refractory marginal zone lymphoma who have previously received two or more systemic treatments.a combination of pettuzumab, trastuzumab and hyaluronidase-zzxf is approved by FDA for the treatment of HER2 positive breast cancer patients who have spread to other parts of the body and early HER2 positive breast cancer patients.approval is 4 months ahead of the target action date.FDA approved pembrolizu mAb monotherapy as the first-line treatment for patients with unresectable or metastatic microsatellite instability (high or mismatch repair defects).on June 29, FDA awarded the title of pbp-1510 orphan drug for the treatment of pancreatic cancer patients.FDA has awarded the title of cirmtuzumab orphan drug for the treatment of mantle cell lymphoma and patients with chronic lymphocytic leukemia or small lymphocytic leukemia.FDA approved avelumab (bavencio) as the first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma who have not yet progressed after first-line platinum chemotherapy.on June 30, the search focused on: cancer gene detection, clinical recruitment, patient communication
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