Global

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.

The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.

The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.

Tocilizumab may represent a potential treatment option with double action against cytokine storm due to COVID-19 in a subset of patients with active multiple myeloma and severe infection with the virus.

Health Canada has approved daratumumab injection, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light chain amyloidosis.

The European Commission has approved isatuximab for use in combination with carfilzomib and dexamethasone in the treatment of patients with relapsed multiple myeloma who have received at least 1 previous therapy.

Samuel Ahuno discusses bringing precision medicine in cancer care to Ghana.

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

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.

Paz Polak, PhD, discusses research that evaluated cancer genomes in Ghana through the use of liquid biopsies.

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.

Michele Ghidini, MD, PhD, discusses the effects of body weight loss in gastric/gastroesophageal junction cancer.

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.

Lewis Au, MBBS, BMedSci, FRACP, discusses the impact that COVID-19 has had and will continue to have on cancer care.

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.