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.

Development of Zandelisib for B-cell Malignancies Discontinued Outside of Japan

December 6th 2022

The development of zandelisib for the treatment of B-cell malignancies has been discontinued outside of Japan.

EMA Accepts Marketing Authorization Application for Momelotinib in Myelofibrosis

December 2nd 2022

The European Medicines Agency has accepted a marketing authorization application for momelotinib as a treatment for patients with myelofibrosis.

EMA Accepts Marketing Authorization Application for Aumolertinib in EGFR-Mutated NSCLC

December 2nd 2022

Pharmaceutical manufacturer EQRx announced December 2, 2022, that the European Medicines Agency has accepted a marketing authorization application for the use of aumolertinib in EGFR-mutated non–small cell lung cancer and locally advanced or metastatic EGFR T790M mutation–positive NSCLC.

Helsinn Birex Pharmaceuticals Withdraws European MAA for Infigratinib for Advanced Cholangiocarcinoma

December 1st 2022

The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.

MHRA Approves Darolutamide Plus ADT and Docetaxel for Metastatic HSPC

November 29th 2022

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved darolutamide tablets in combination with androgen deprivation therapy and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.

NICE Recommends Nivolumab/Chemo for HER2- Advanced Stomach and Esophageal Cancer

November 29th 2022

The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of nivolumab plus chemotherapy as a treatment option for patients with HER2-negative advanced stomach and esophageal cancer.

European Commission Approves Cemiplimab for Recurrent or Metastatic Cervical Cancer

November 22nd 2022

The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.

European Commission Approves Zanubrutinib for CLL

November 18th 2022

The European Commission has approved zanubrutinib for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia.

NICE Recommends Mobocertinib for Rare, Aggressive Lung Cancer

November 16th 2022

The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of mobocertinib for patients with advanced non–small cell lung cancer harboring EGFR exon 20 insertion mutations who have already received platinum-based chemotherapy.

Ivonescimab Receives Breakthrough Therapy Designation for IO-Resistant NSCLC in China

November 16th 2022

The Center for Drug Evaluation of the China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab plus docetaxel for patients with locally advanced or metastatic non–small cell lung cancer who failed to respond to a prior PD-(L)1 inhibitor plus platinum-based doublet chemotherapy.

Second-line Fruquintinib Plus Paclitaxel Improves PFS in Chinese Patients With Gastric Cancer

November 15th 2022

The addition of fruquintinib to paclitaxel in the second-line treatment of Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma significantly improved progression-free survival over paclitaxel alone.

Olaparib Combo Approaches EU Approval for Select Patients With mCRPC

November 14th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib in combination with abiraterone acetate and prednisone or prednisolone for use in adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not indicated.

Ibrutinib Demonstrates Long-Term Efficacy in CLL in Real-World Setting

November 3rd 2022

Ibrutinib induced a cumulative overall response rate of 90.0% in 3-year findings from the Belgian Ibrutinib Real‑World Data study of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia.

Ivonescimab Gets Breakthrough Therapy Designation in China for EGFR+ Advanced NSCLC

October 21st 2022

The China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab for use in combination with chemotherapy in patients with EGFR-mutated advanced non–small cell lung cancer in whom prior treatment with an EGFR TKI has failed.

European Commission Approves Second-line Axi-cel for DLBCL/HGBL

October 18th 2022

The European Commission has approved axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma or high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Pluvicto Receives Support for European Approval in PSMA-Positive mCRPC

October 14th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Lutetium 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.

EMA Endorses Cemiplimab Approval in Advanced Cervical Cancer

October 14th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for cemiplimab monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy.

Japan Green Lights Valemetostat Tosilate for Relapsed/Refractory Adult T-cell Leukemia/Lymphoma

September 26th 2022

The Japan Ministry of Health, Labor and Welfare has approved valemetostat tosilate for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma.

China Green Lights Olaparib for First-line Maintenance in HRD+ Advanced Ovarian Cancer

September 22nd 2022

Olaparib plus bevacizumab was approved in China as a first-line maintenance treatment for homologous recombination deficiency–positive ovarian cancer following a response to platinum-based chemotherapy plus bevacizumab.

Frontline Toripalimab Plus Chemotherapy Approved in China for Advanced Nonsquamous NSCLC

September 20th 2022

The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.