Global Oncology | Specialty

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.

Fixed-Duration Ibrutinib Plus Venetoclax Wins EU Approval in Previously Untreated CLL

August 25th 2022

The European Commission has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia.

European Commission Grants Conditional Marketing Authorization to Teclistamab for Multiple Myeloma

August 24th 2022

The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

European Union Green Lights PD-L1 Companion Diagnostic for Adjuvant Atezolizumab in NSCLC

August 24th 2022

CE label expansion was granted to the Ventana PD-L1 assay for use as a companion diagnostic to identify patients with non–small cell lung cancer who are eligible for treatment with adjuvant atezolizumab.

Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC

August 23rd 2022

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

EMA Accepts Marketing Authorization Application for Fixed-Dose Decitabine/Cedazuridine Combo in AML

August 22nd 2022

The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.

EMA Accepts Marketing Authorization Application for Elacestrant in ER+/HER2- Advanced Breast Cancer

August 22nd 2022

The European Medicines Agency has validated a marketing authorization application for elacestrant for estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.

UK’s MHRA Extends Conditional Marketing Authorization for Trastuzumab Deruxtecan to Select HER2+ Metastatic Breast Cancer

August 18th 2022

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 2022

The 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.

INBRX-109 Granted Orphan Drug Designation in Europe for Chondrosarcoma

August 16th 2022

The European Commission has granted an orphan medicinal product designation to INBRX-109 for use as a potential therapeutic option in patients with chondrosarcoma.

Sintilimab Combo Extends PFS in Previously Treated EGFR-Mutated NSCLC

August 3rd 2022

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

August 2nd 2022

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%

July 23rd 2022

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

July 21st 2022

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

July 21st 2022

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.

Trastuzumab Deruxtecan Approved in Europe for HER2+ Metastatic Breast Cancer Treated With 1 or More Prior Anti–HER2-Based Regimens

July 19th 2022

The European Commission has approved fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least 1 anti–HER2-based regimen.

Pralsetinib Approved for RET Fusion+ Metastatic NSCLC in Hong Kong, China

July 18th 2022

Pralsetinib has been approved in Hong Kong, China, for use in treatment-naïve and pretreated adult patients with RET fusion–positive, metastatic non–small cell lung cancer.

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.