[{"orgOrder":0,"company":"Onco360","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"REZUROCK\u2122 Tablets Approved to Treat Adult and Pediatric Patients 12 Years and Older With Chronic Graft-Versus-Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"CTI BioPharma Corp","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VONJO\u2122 (pacritinib) Now Approved for the Treatment of Adults with Intermediate or High-Risk Primary or Secondary Myelofibrosis with a Platelet Count Below 50 x 109\/L","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"Myovant Sciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ORGOVYX\u00ae (relugolix) Now Available from Onco360 for the Treatment of Adult Patients with Advanced Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"Servier","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TIBSOVO\u00ae (ivosidenib) Now Available from Onco360 for the Treatment of Adult Patients with IDH1-Mutant Acute Myeloid Leukemia or Previously Treated, IDH1-Mutant Metastatic Cholangiocarcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jaypirca\u2122 (pirtobrutinib) Now Available from Onco360 for the Treatment of Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma (MCL) after at least Two Lines of Systemic Therapy, Including a BTK Inhibitor","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ORSERDU\u2122 Now Available from Onco360 for the Treatment of Postmenopausal Women or Adult Men, with ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer with Disease Progression Following at Least One Line of Endocrine Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Onco360","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lytgobi\u00ae (futibatinib) Now Available from Onco360 for the Treatment of Adult Patients with Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Gene Fusions or Other Rearrangements","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
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Lytgobi (futibatinib) is a small molecule kinase inhibitor of FGFR. It has demonstrated anti-tumor activity by inhibiting FGFR phosphorylation and downstream signaling and decreased cell viability in cancer cell lines with FGFR alterations.
Orserdu (elacestrant) is an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα). It inhibits 17β-estradiol mediated cell proliferation at concentrations inducing degradation of ERα protein mediated through proteasomal pathway.
Jaypirca (pirtobrutinib) is a small molecule and a highly selective non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). Its high selectivity has been associated with lower discontinuation rates due to adverse events and a lower incidence of atrial fibrillation.
TIBSOVO® (ivosidenib), which is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed acute myeloid leukemia (AML).
ORGOVYX® (relugolix), which is a gonadotropin-releasing hormone (GnRH) antagonist that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer.
FDA’s approval of VONJO (pacritinib) is based upon results of PERSIST-2 clinical trial indicate that 29% of myelofibrosis patients with baseline platelet levels of less than 50 x 109/L obtained spleen volume reductions of at least 35% during first six months of VONJO therapy.
The FDA’s approval of REZUROCK comes as a result of the Phase II KD025-213 clinical trial which demonstrated 75% overall response rate after six cycles of therapy at a dose of 200mg orally once daily in patients with chronic GVHD disease.