Mobocertinib Receives Approval in China for Previously Treated EGFR Exon 20 Insertion–Mutated NSCLCJanuary 11th 2023
The National Medical Products Administration of China gives approval to mobocertinib for patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations.
Durvalumab/Tremelimumab Approved in Japan for Advanced NSCLC and Select Unresectable GI CancersJanuary 4th 2023
The decision to approve durvalumab plus tremelimumab in Japan for patients with advanced non–small cell lung cancer and unresectable biliary tract cancer and liver cancer was based on data from several phase 3 studies.
EU Approves Fam-Trastuzumab Deruxtecan-nxki HER2+ Advanced Gastric CancerDecember 22nd 2022
Patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma in the European Union can now receive treatment with fam-trastuzumab deruxtecan-nxki following its approval.
EU’s CHMP Recommends Fam-Trastuzumab Deruxtecan-nxki for Approval in HER2-Low Breast CancerDecember 20th 2022
Fam-trastuzumab deruxtecan-nxki has been recommended for approval by the European Union’s Committee for Medicinal Products for Human Use in patients with HER2-low advanced breast cancer.
European Commission Approves 177Lu Vipivotide Tetraxetan Plus ADT for Prostate Cancer SubsetDecember 17th 2022
177Lu vipivotide tetraxetan becomes first targeted radioligand treatment approved by the European Commission for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
European Commission Approves Cemiplimab for Recurrent/Metastatic Cervical CancerNovember 23rd 2022
The European Commission’s approval of cemiplimab for recurrent or metastatic cervical cancer marks the first second-line immunotherapy option available for this patient population regardless of tumor histology.
Mobocertinib Receives Positive NICE Opinion for Previously Treated EGFR Exon 20 Insertion–Mutated NSCLCNovember 22nd 2022
The National Institute for Health and Care Excellence has given a positive opinion of mobocertinib as a treatment for previously treated advanced non-small cell lung cancer with EGFR exon 20 insertion mutations.
European Commission Grants Approval to Second-Line Axicabtagene Ciloleucel for R/R DLBCL/HGBLOctober 22nd 2022
The European Commission based its approval of axicabtagene ciloleucel as a second-line therapy for patients with relapsed/refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma on the efficacy findings of the phase 3 ZUMA-7 trial.
Pembrolizumab Granted 4 Approvals in Japan for High-Risk TNBC, RCC, and MoreOctober 2nd 2022
Japan’s Ministry of Health, Labor and Welfare approved pembrolizumab for use in 4 indications, including high-risk, early-stage triple-negative breast cancer, stage IIB or IIC melanoma, adjuvant renal cell carcinoma, and recurrent/metastatic cervical cancer.
European Commission Approves Nivolumab/Relatlimab Combo for Treatment of Unresectable or Metastatic MelanomaSeptember 25th 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 CancerSeptember 23rd 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 CMLAugust 29th 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 CancerAugust 5th 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 IndicationJuly 27th 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 MyelomaJuly 24th 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 CancerJuly 19th 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 CancerJune 29th 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.