The OncLive® Global Oncology condition center page is a comprehensive resource for clinical news and international expert insights on treatment of patients with cancer. This page features articles focused on ex-US regulatory news, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing global research in oncology care.
Repotrectinib NDA Under NMPA Review for Locally Advanced or Metastatic ROS1+ NSCLC
June 28th 2023The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.
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Sacituzumab Govitecan Approaches EU Approval for Pretreated HR+ Metastatic Breast Cancer
June 23rd 2023The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.
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European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC
June 16th 2023The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.
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Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy
June 7th 2023A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.
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EMA Committee Recommends Piflufolastat 18F PSMA PET Imaging Agent for Prostate Cancer
June 1st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.
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Olverembatinib Recommended for Breakthrough Therapy Designation in China for SDH-Deficient GIST
June 1st 2023The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.
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European Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Myeloma
May 26th 2023A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.
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EMA Recommends Approval of Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC
May 26th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.
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Quizartinib Garners Approval in Japan for Newly Diagnosed FLT3-ITD+ AML
May 26th 2023Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.
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China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC
May 23rd 2023The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.
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The National Institute for Health and Care Excellence has recommended the combination of pembrolizumab and lenvatinib for use in previously treated patients with advanced or recurrent endometrial cancer whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.
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Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point
May 18th 2023Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.
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IBI351 Receives Breakthrough Therapy Designation in China for Previously Treated Advanced CRC
May 16th 2023China’s National Medical Products Administration has granted a breakthrough therapy designation to the KRAS G12C inhibitor IBI351 as monotherapy for previously treated patients with advanced colorectal carcinoma harboring a KRAS G12C mutation.
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China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia
May 8th 2023China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.
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Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy
May 3rd 2023The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
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First-line Cemiplimab Plus Chemo Wins Approval in Canada for Advanced NSCLC
May 2nd 2023Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.
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Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC
April 24th 2023The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.
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HECTOR Deep Learning Model Shows Predictability for Distant Recurrence Risk in Endometrial Cancer
April 18th 2023A deep learning risk prediction model was able to accurately identify patients with endometrial cancer at low and high risk of distant recurrence, according to data presented during the 2023 AACR Annual Meeting.
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Adjuvant Atezolizumab Plus Bevacizumab Significantly Improves RFS in High-risk HCC
April 16th 2023Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.
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EMA Awards PRIME Scheme Designation to mRNA-4157/V940 Plus Pembrolizumab in High-risk Melanoma
April 7th 2023The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.
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NICE Guidance Supports Olaparib Use in BRCA-Mutant Breast, Prostate Cancer
April 7th 2023The National Institute for Health and Care Excellence announced final draft guidance recommending the PARP inhibitor olaparib for patients with HER2-negative, high-risk early breast cancer harboring a BRCA1/2 mutation, as well as for those with previously treated hormone-relapsed metastatic prostate cancer with a BRCA1/2 mutation.
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Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL
March 31st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.
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European Commission Approves Cemiplimab Plus Chemotherapy for First-line PD-L1+ NSCLC
March 29th 2023The European Commission has approved cemiplimab-rwlc plus platinum-based chemotherapy for the frontline treatment of patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without EGFR, ALK, or ROS1 alterations and who are not eligible for chemoradiation.
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Fixed-Duration Ibrutinib Plus Venetoclax Earns Approval in Canada for Previously Untreated CLL
March 28th 2023Canada Health has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.
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Trastuzumab Deruxtecan Garners Approval in Japan for HER2-Low Metastatic Breast Cancer
March 27th 2023Japan’s Ministry of Health, Labor and Welfare has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.
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Acalabrutinib Receives Approval in China for Relapsed/Refractory Mantle Cell Lymphoma
March 23rd 2023Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
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