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.

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.

Zanubrutinib Approaches European Approval for Marginal Zone Lymphoma

September 19th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.

Relatlimab Plus Nivolumab Approved in Europe for Unresectable or Metastatic Melanoma with PD-L1 <1%

September 17th 2022

The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.

Tislelizumab Provides Favorable Efficacy in Asian and Non-Asian Patients with Previously Treated Advanced NSCLC

September 12th 2022

Tislelizumab continued to demonstrate an improved clinical benefit compared with docetaxel in both Asian and non-Asian patients with previously treated advanced non–small cell lung cancer.

European Commission Grants Orphan Drug Designation to Nana-val for Peripheral T-cell Lymphoma

September 8th 2022

The European Commission has granted an orphan drug designation to nanatinostat and valganciclovir for use as a potential therapeutic option in patients with peripheral T-cell lymphoma.

Approval Sought for Tafasitamab/Lenalidomide Combo in R/R DLBCL in Hong Kong

August 31st 2022

The Hong Kong Special Administrative Region’s Department of Health has accepted for review a biologics license application seeking the approval of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.

Daiichi Sankyo Submits sNDA for Quizartinib in Newly Diagnosed FLT3-ITD+ AML in Japan

August 30th 2022

Daiichi Sankyo submitted a supplemental new drug application to Japan’s Ministry of Health, Labor, and Welfare for the use of quizartinib in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

EU Approves Asciminib for Ph+ CML in Chronic Phase After 2 or More TKIs

August 29th 2022

The European Commission has approved asciminib for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who received prior treatment with at least 2 TKIs

Adjuvant Osimertinib Gets Japanese Approval for Early-Stage, EGFR-Mutated NSCLC

August 26th 2022

The Japanese Ministry of Health, Labour, and Welfare has approved osimertinib for use as an adjuvant treatment in patients with EGFR-mutated non–small cell lung cancer.