The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alteration, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
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The FDA has approved pembrolizumab (Keytruda) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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The European Medicines Agency (EMA) has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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FDA Approves RAS Mutation Detection Kit as Companion Diagnostic for Panitumumab in mCRC
October 20th 2023The FDA has approved the CRCdx RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer (mCRC), according to an announcement from EntroGen.
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FDA Grants Fast Track Designation to IDE161 for BRCA+, Platinum-Resistant Advanced Ovarian Cancer
September 30th 2023The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and poly-ADP ribose polymerase, or PARP, inhibitor therapies.
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Second-Line Axi-Cel Produces Complete Metabolic Responses in Transplant-Ineligible LBCL
August 24th 2023Second-line treatment with axicabtagene ciloleucel (axi-cel) led to an investigator-assessed, 3-month complete metabolic response rate of 71.0% in patients with large B-cell lymphoma (LBCL) who were ineligible for autologous stem cell transplant.
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Gilead Discontinues Phase 3 ENHANCE Trial of Magrolimab/Azacitidine in Higher-Risk MDS
August 7th 2023The phase 3 ENHANCE trial evaluating the first-line combination of magrolimab and azacitidine vs placebo plus azacitidine in patients with higher-risk myelodysplastic syndrome has been discontinued due to futility at a planned analysis.
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China Approves Zanubrutinib in Treatment-Naïve CLL/SLL and Waldenström Macroglobulinemia
May 9th 2023China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.
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FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast Cancer
January 27th 2023The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.
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