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.

European Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Myeloma

May 26th 2023

A 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.

EMA Recommends Approval of Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC

May 26th 2023

The 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%.

Quizartinib Garners Approval in Japan for Newly Diagnosed FLT3-ITD+ AML

May 26th 2023

Japan’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.

China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC

May 23rd 2023

The 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.

NICE Recommends Pembrolizumab Plus Lenvatinib for Previously Treated Advanced or Recurrent Endometrial Cancer

May 22nd 2023

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.

Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point

May 18th 2023

Roxadustat 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.

IBI351 Receives Breakthrough Therapy Designation in China for Previously Treated Advanced CRC

May 16th 2023

China’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.

China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia

May 8th 2023

China’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.

Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy

May 3rd 2023

The 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.

First-line Cemiplimab Plus Chemo Wins Approval in Canada for Advanced NSCLC

May 2nd 2023

Health 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.

Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC

April 24th 2023

The 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.

HECTOR Deep Learning Model Shows Predictability for Distant Recurrence Risk in Endometrial Cancer

April 18th 2023

A 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.

Adjuvant Atezolizumab Plus Bevacizumab Significantly Improves RFS in High-risk HCC

April 16th 2023

Adjuvant 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.

NHS Scotland Grants Trastuzumab Deruxtecan Approval for Use in Pretreated HER2+ Metastatic Breast Cancer

April 12th 2023

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have received 1 prior anti–HER2-based therapy.

EMA Awards PRIME Scheme Designation to mRNA-4157/V940 Plus Pembrolizumab in High-risk Melanoma

April 7th 2023

The 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.

NICE Guidance Supports Olaparib Use in BRCA-Mutant Breast, Prostate Cancer

April 7th 2023

The 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.

Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL

March 31st 2023

The 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.

European Commission Approves Cemiplimab Plus Chemotherapy for First-line PD-L1+ NSCLC

March 29th 2023

The 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.

Fixed-Duration Ibrutinib Plus Venetoclax Earns Approval in Canada for Previously Untreated CLL

March 28th 2023

Canada 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.

Trastuzumab Deruxtecan Garners Approval in Japan for HER2-Low Metastatic Breast Cancer

March 27th 2023

Japan’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.