Global Oncology

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.

Health Canada has approved relugolix for the treatment of men with advanced prostate cancer.

The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.

Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.

The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.

The European Commission has approved brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.

The European Medicines Agency’s Committee for Orphan Medical Products has granted orphan drug designation to LSTA1 for the treatment of patients with pancreatic cancer.

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of dostarlimab plus chemotherapy for the treatment of adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

The European Commission has approved pembrolizumab as adjuvant monotherapy for the treatment of adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.

The Medicines and Healthcare Products Regulatory Agency has authorized the use of dostarlimab in combination with chemotherapy for the treatment of patients with mismatch repair-deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.

The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.

Epcoritamab-bysp has been approved by the European Commission and Japan's Ministry of Health, Labour, and Welfare for the treatment of select patients with relapsed/refractory large B-cell lymphoma.

The European Commission has granted marketing authorization for Enrylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month and older who developed hypersensitivity or silent inactivation to E. coli–derived asparaginase.

The European Commission has approved elacestrant for the treatment of postmenopausal women and men with estrogen receptor–positive, HER2-negative, locally advanced, or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least 1 line of endocrine therapy including a CDK4/6 inhibitor.

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

The European Commission has approved oral decitabine and cedazuridine for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for standard induction chemotherapy.

The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.