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.
The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.
European Commission Approves Melphalan Flufenamide for Relapsed/Refractory Multiple Myeloma
August 18th 2022The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.
Sintilimab Combo Extends PFS in Previously Treated EGFR-Mutated NSCLC
Sintilimab in combination with a bevacizumab biosimilar plus pemetrexed and cisplatin induced a progression-free survival benefit of 2.6 months compared with chemotherapy alone for patients with EGFR-mutated, locally advanced or metastatic non–small cell lung cancer, according to interim findings from the ongoing phase 3 ORIENT-31 trial.
Ropeginterferon Alfa-2b Proves to be Efficacious, Safe in Japanese Patients with Polycythemia Vera
Ropeginterferon alfa-2b produced durable complete hematologic responses without phlebotomy and showcased a consistent safety profile in Japanese patients with polycythemia vera, according to findings from a phase 2 study (NCT04182100) presented during the 2022 EHA Congress.
Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab and relatlimab for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.
Eltanexor Gets FDA Fast Track Status and Orphan Medicinal Product Designation in Europe for MDS
Eltanexor has been granted a fast track designation from the FDA and an orphan medicinal product designation from the European Commission for use as a potential therapeutic option in patients with myelodysplastic syndromes.
Selinexor Combo Approved in Europe for Multiple Myeloma After at Least 1 Prior Therapy
The European Commission granted a full marketing authorization to selinexor in combination with once-weekly bortezomib and low-dose dexamethasone for the treatment of adults with multiple myeloma who have received at least 1 previous therapy.
Axi-cel Gains European Approval for Relapsed/Refractory Follicular Lymphoma
The European Commission has granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after 3 or more prior lines of systemic therapy.
Olaparib Approaches EU Approval for BRCA+, High-Risk Early Breast Cancer
June 27th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.
Asciminib Moves Toward EU Approval for Ph+ CML in Chronic Phase
June 24th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.
CHMP Recommends Melphalan Flufenamide for Triple-Class Refractory Multiple Myeloma
The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.
Capmatinib Approved in Europe for METex14-Altered Advanced NSCLC
June 22nd 2022The European Commission has approved capmatinib as a single agent for the treatment of patients with MET exon14 skipping–altered advanced non–small cell lung cancer who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
European Medicines Agency Validates Type II Variation Application for Liso-cel in Second-line LBCL
June 20th 2022The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.
Repotrectinib Receives Breakthrough Therapy Designations in China for ROS1+ NSCLC
The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.
Adjuvant Atezolizumab Approved in Europe for High-Risk NSCLC With PD-L1 of ≥50%
The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.
Mosunetuzumab Approved in Europe for Relapsed/Refractory Follicular Lymphoma
The European Commission has granted a conditional marketing authorization for mosunetuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 systemic therapies.
Zanubrutinib Approved in Uruguay for MCL, MZL, and Waldenström Macroglobulinemia
The BTK inhibitor zanubrutinib has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma, relapsed or refractory marginal zone lymphoma, and Waldenström macroglobulinemia.
Polatuzumab Vedotin Plus R-CHP Approved in Europe for Previously Untreated DLBCL
The European Commission has approved the combination of polatuzumab vedotin and rituximab and cyclophosphamide, doxorubicin, and prednisone for use in adult patients with previously untreated diffuse large B-cell lymphoma.
Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma
May 20th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.
European Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC
A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.
Selinexor Combo Approaches EU Approval for Refractory Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.
Tisagenlecleucel Approved in Europe for Relapsed/Refractory Follicular Lymphoma
The European Commission has approved the CD19-targeting chimeric antigen receptor T-cell agent tisagenlecleucel for the treatment of adults with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.
The European Commission has approved the use of cabozantinib for use as a single agent in adult patients with locally advanced or metastatic differentiated thyroid carcinoma who are refractory or not eligible to receive radioactive iodine and who have progressed during or following previous systemic treatment.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab alone after surgery for adult patients with locally advanced or early-stage triple-negative breast cancer who are at a high risk for recurrence.
Mosunetuzumab Approaches EU Approval for Relapsed or Refractory Follicular Lymphoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval under conditional marketing authorization for mosunetuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 therapies.
EU Panel Recommends Capmatinib for METex14-Altered Advanced NSCLC
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.