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.
Durvalumab Plus Chemo Wins Approval in China For Advanced/Metastatic Biliary Tract Cancer
November 14th 2023China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.
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CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications
November 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer
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Momelotinib Approaches EU Approval for Myelofibrosis With Anemia
November 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.
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CHMP Recommends Adagrasib for Pretreated KRAS G12C+ Advanced NSCLC
November 14th 2023After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.
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Frontline Pembrolizumab Plus Chemo Approaches EU Approval for Biliary Tract Cancer
November 10th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer
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Frontline Cadonilimab Plus Chemotherapy Improves OS in Advanced Gastric/GEJ Adenocarcinoma
November 7th 2023First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.
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EU Approval Sought for Encorafenib/Binimetinib in BRAF V600+ Advanced NSCLC
November 2nd 2023The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.
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Elranatamab Approaches EU Approval for Heavily Pretreated Relapsed/Refractory Multiple Myeloma
November 1st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of elranatamab-bcmm for the treatment of adult patients with relapsed/refractory multiple myeloma who were previously treated with 3 or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who experienced disease progression on their last therapy.
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EMA Validates Application for Frontline Nivolumab Plus Chemo in Advanced Urothelial Cancer
October 30th 2023The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.
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The European Medicines Agency 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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Epcoritamab Receives UK Approval for R/R DLBCL After 2 Prior Lines of Therapy
October 24th 2023The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.
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Trastuzumab Deruxtecan Wins EU Approval for HER2-Mutated Advanced NSCLC
October 23rd 2023The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
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Amivantamab Plus Chemotherapy Nearly Doubles PFS in EGFR Exon 20–Mutant NSCLC
October 21st 2023The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.
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Selpercatinib Significantly Improves PFS Vs Chemo With or Without Pembrolizumab in RET+ NSCLC
October 21st 2023Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.
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Zanubrutinib Receives NICE Recommendation for Treatment of CLL
October 20th 2023The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.
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EU Panel Recommends Rucaparib for Frontline Maintenance in Advanced Ovarian Cancer
October 17th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.
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Neoadjuvant Daromun Elicits RFS Benefit in Locally Advanced, Fully Resectable Melanoma
October 16th 2023Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.
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CHMP Recommends Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced/Recurrent Endometrial Cancer
October 16th 2023The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of dostarlimab plus chemotherapy for the treatment of adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
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European Commission Approves Adjuvant Pembrolizumab for High-Risk NSCLC
October 16th 2023The European Commission has approved pembrolizumab as adjuvant monotherapy for the treatment of adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
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The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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Zanubrutinib Plus Obinutuzumab Approaches EU Approval in R/R Follicular Lymphoma
October 13th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.
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European Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC
October 6th 2023A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.
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EMA Validates MAA for Imetelstat for Transfusion-Dependent Anemia in Lower-Risk MDS
October 3rd 2023The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.
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Japanese Approval Sought for Fruquintinib in Previously Treated Metastatic Colorectal Cancer
October 2nd 2023A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.
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Epcoritamab Wins European and Japanese Approval for Select Types of R/R LBCL
September 25th 2023Epcoritamab-bysp has been approved by the European Commission and Japan's Ministry of Health, Labour, and Welfare for the treatment of select patients with relapsed/refractory large B-cell lymphoma.
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European Commission Approves Enrylaze for ALL and Lymphoblastic Lymphoma
September 22nd 2023The European Commission has granted marketing authorization for Enrylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month and older who developed hypersensitivity or silent inactivation to E. coli–derived asparaginase.
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