Global Bulletin

European Commission Approves Nivolumab/Relatlimab Combo for Treatment of Unresectable or Metastatic Melanoma
September 25, 2022

The European Commission based its approval of nivolumab/relatlimab for patients with a PD-L1 expression of less than 1% on the results of the phase 2/3 RELATIVITY-047 trial.

First-Line Olaparib/Bevacizumab Maintenance Combo Approved in China for HRD+ Advanced Ovarian Cancer
September 23, 2022

Olaparib and bevacizumab has been approved in China as a frontline maintenance treatment for patients with advanced homologous recombination deficiency–positive ovarian cancer based on results from the phase 3 PAOLA-1 trial.

European Commission Approves Asciminib in Philadelphia Chromosome–Positive CML
August 29, 2022

Results from the phase 3 ASCEMBL trial led to the approval of asciminib by the European Commission for patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Adjuvant Olaparib Approved in European Union for BRCA1/2-Positive, HER2-Negative High-Risk Early Breast Cancer
August 05, 2022

The European Commission approved olaparib as monotherapy or in combination with endocrine therapy for patients with germline BRCA1/2-mutant, HER2-negative high-risk early breast cancer.

EMA Gives Positive CHMP Opinion for Teclistamab Relapsed/Refractory Myeloma Indication
July 27, 2022

Patients with relapsed/refractory multiple myeloma appear to benefit from treatment with teclistamab, which was given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Full Marketing Authorization Granted to Selinexor Combo by European Commission for Pretreated Multiple Myeloma
July 24, 2022

Patients in Europe who have multiple myeloma and have received at least 1 previous therapy can now receive treatment with selinexor plus bortezomib and low-dose dexamethasone following its full marketing authorization by the European Commission.

Trastuzumab Deruxtecan Receives EU Approval for Previously Treated Unresectable/Metastatic HER2+ Breast Cancer
July 19, 2022

European patients with unresectable or metastatic HER2-positive breast cancer are now able to receive treatment with trastuzumab deruxtecan following 1 or more previous anti-HER2 regimens.

European Medicines Agency Recommends T-DXd for Approval in European Union in Advanced HER2+ Breast Cancer
June 29, 2022

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended for approval trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive breast cancer.

Adjuvant Pembrolizumab Approved by European Commission for Resected Stage IIB/C Melanoma
June 24, 2022

Patients with fully resected stage IIB or IIC melanoma can now receive treatment with pembrolizumab in the adjuvant setting following its approval by the European Commission.

European Commission Approves Capmatinib in NSCLC With MET Exon 14 Skipping Mutation
June 22, 2022

Based on results from the phase 2 GEOMETRY mono-1 trial, the European Commission has approved capmatinib for patients with non–small cell lung cancer who have MET exon 14 skipping mutations, and a need for systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.