Global Oncology

The China National Medical Products Administration has approved osimertinib for use as an adjuvant treatment in patients with early-stage non–small cell lung cancer with EGFR exon 19 deletions or exon 21 mutations, following tumor resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient’s physician.

Daratumumab appears to be safe when used as consolidation therapy in patients with multiple myeloma, even soon after autologous stem cell transplant, and the agent has also demonstrated early efficacy in the setting of very good responders.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of single-agent duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia following at least 2 prior therapies, and follicular lymphoma that is refractory to at least 2 prior systemic treatments.

A new drug application has been submitted to the FDA and the China National Medical Products Administration for the use of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.

Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.

Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.

The European Medicines Agency has validated a Marketing Authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had previously received at least 2 therapies, including at least 1 therapy for locally advanced or metastatic disease.

The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.

Adagrasib yielded durable responses and broad disease control, in addition to providing extensive predicted coverage throughout the dosing interval, in patients with KRAS G12C–mutant advanced non–small cell lung cancer.

The Japanese Ministry of Health, Labour, and Welfare has approved pemigatinib for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening following chemotherapy.

CA-125 surveillance alone could be used to detect disease progression in patients with advanced ovarian cancer and an abnormal CA-125 level at the beginning of frontline maintenance therapy with olaparib and bevacizumab, according to an analysis from the phase 3 PAOLA-1.

QIAGEN and INOVIO Pharmaceuticals, Inc. are extending their collaborative efforts with a new agreement to develop liquid biopsy–based companion diagnostic assays for INOVIO agents, according to a news release from INOVIO.

The addition of daratumumab to lenalidomide and dexamethasone resulted in improved progression-free survival vs Rd alone in patients with newly diagnosed multiple myeloma who were not eligible for transplant—even in frail patients.

The European Commission has approved an expanded label for pembrolizumab for use as a single agent in the treatment of select adult and pediatric patients aged 3 years and older who have relapsed/refractory classical Hodgkin lymphoma.

The United Kingdom’s National Institute for Health and Care Excellence will not recommend olaparib for the treatment of patients with hormone-relapsed, metastatic prostate cancer that harbors BRCA1 or BRCA2 mutations that has progressed on abiraterone acetate or enzalutamide.

Teclistamab demonstrated encouraging clinical activity, along with a tolerable safety profile, in patients with relapsed/refractory multiple myeloma.

Maintenance treatment with lenalidomide was found to be a safe treatment for patients with multiple myeloma who are diagnosed with COVID-19, supporting use of the immunomodulatory drug in this patient population.

The triplet regimen of melphalan flufenamide with dexamethasone and either daratumumab or bortezomib demonstrated encouraging clinical activity and was well tolerated in patients with heavily pretreated relapsed/refractory multiple myeloma.

Ixazomib-based triplet regimens as induction therapy elicited higher rates of efficacy compared with ixazomib/dexamethasone alone, followed by single-agent ixazomib maintenance, in patients with transplant-ineligible newly diagnosed multiple myeloma.

Health Canada has approved the BTK inhibitor zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.

February 26, 2021 - The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion to dostarlimab as a treatment for patients with recurrent or advanced microsatellite instability–high/mismatch repair deficient endometrial cancer who have progressed on or following platinum-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.