OncLive Global

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.

Axi-cel Gains European Approval for Relapsed/Refractory Follicular Lymphoma

June 28th 2022

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 2022

The 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.

Adjuvant Pembrolizumab Wins European Approval for Stage IIB/IIC Melanoma Following Complete Resection

June 24th 2022

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

Asciminib Moves Toward EU Approval for Ph+ CML in Chronic Phase

June 24th 2022

The 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

June 23rd 2022

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 2022

The 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 2022

The 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

June 17th 2022

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%

June 14th 2022

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

June 8th 2022

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

May 27th 2022

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

May 26th 2022

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 2022

The 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

May 20th 2022

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

May 20th 2022

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

May 17th 2022

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.

Cabozantinib Approved in Europe for Second-Line Radioactive Iodine–Refractory Differentiated Thyroid Cancer

May 3rd 2022

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.

Neoadjuvant Pembrolizumab/Chemo Followed by Adjuvant Pembrolizumab Approaches EU Approval for High-Risk, Early-Stage TNBC

April 26th 2022

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

April 25th 2022

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

April 23rd 2022

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.