Global

December 11, 2020 - The European Medicine Agency’ s Committee for Medicinal Products for Human Use has granted a positive opinion to avelumab as a single agent, frontline maintenance option for adult patients with locally advanced or metastatic urothelial carcinoma who are free of disease progression after platinum-based chemotherapy.

December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.

December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

December 10, 2020 — The combination of ipatasertib and paclitaxel failed to show a significant improvement in progression-free survival vs placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer.

December 10, 2020 - Treatment with abemaciclib in combination with endocrine therapy significantly reduced the risk of invasive disease recurrence or death in patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer who had high Ki-67 tumors, suggesting that this feature can be used in conjunction with high-risk features to select patients for abemaciclib in the adjuvant setting.

Robert Zeiser, MD, discusses results of the REACH3 trial in chronic graft-versus-host disease.

Christian Buske, MD, discusses ​the results of the iNNOVATE trial in Waldenström macroglobulinemia.

Nigerian patients with prostate cancer are noted as having higher levels of total plasma peroxide, malondialdehyde, and nitric oxide, as well as lower levels of total antioxidant capacity, even while undergoing androgen-deprivation therapy compared with Nigerian men who don't have prostate cancer.

Vincent J. Picozzi Jr, MD, spotlights the launch of PanCAN’s Precision Promise clinical trial platform, and how it is expected to impact clinical practice.

The Japanese Ministry of Health, Labor, and Welfare has approved cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma that has progressed on prior systemic therapy.

November 23, 2020 - The China National Medical Products Administration has approved denosumab for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in those with multiple myeloma.

Regulatory applications have been submitted to the FDA and the European Medicines Agency for subcutaneous daratumumab for use in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.

November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.

November 10, 2020 - The European Union approved the next-generation BTK inhibitor acalabrutinib for use in adult patients with chronic lymphocytic leukemia.

The European Commission has approved the combination of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the up-front treatment of adult patients with metastatic non–small cell lung cancer without a sensitizing EGFR mutation or an ALK translocation.

The European Union has approved olaparib in combination with bevacizumab for use as a first-line maintenance treatment in patients with homologous recombination deficient–positive advanced ovarian cancer.

The European Commission has approved the combination of atezolizumab plus bevacizumab for use in adult patients with advanced or unresectable hepatocellular carcinoma who have not been given previous systemic therapy.

The China National Medical Products Administration has approved the combination of atezolizumab plus bevacizumab for use in patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy.

The European Commission has approved niraparib for use as a frontline monotherapy maintenance option in adult patients with advanced epithelial, high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response after platinum-based chemotherapy.

A supplemental application was submitted to the Japanese Ministry of Health, Labour, and Welfare for Manufacturing and Marketing approval of the combination of cabozantinib plus nivolumab for the treatment of patients with unresectable, advanced, or metastatic renal cell carcinoma.

Alessandro Gronchi, MD, discusses ​the results of the ​phase 2 TRASTS trial in soft tissue sarcoma.

Arun Azad, PhD, discusses the significance of the PROfound trial in metastatic castration-resistant prostate cancer.

Ray McDermott, discusses preventing recurrence in patients with very high-risk prostate cancer.

Zarnie Lwin, MBBS, FRACP, discusses the design of the phase 2 LEAP-005 trial in previously treated patients with advanced solid tumors.

Patricia Pautier, MD, discusses the results of the phase 2 LMS-02 trial with doxorubicin and trabectedin in ​uterine and soft tissue leiomyosarcoma.

New data showing efficacy and tolerability with ADP-A2AFP, alpha-fetoprotein–directed specific peptide enhanced affinity receptor T-cells, suggest that further research evaluating the 5 billion or more cell dosing regimen is warranted in hepatocellular carcinoma.

Nicole Concin, MD, discusses the rationale for the ​phase 1/2 LIO-1 trial in advanced gynecologic malignancies.

Patricia Pautier, MD, discusses limitations in leiomyosarcoma.

The combination of bavituximab and pembrolizumab demonstrated synergistic antitumor activity and was well tolerated in patients with pretreated advanced gastric or gastroesophageal junction cancer.

Rebecca Kristeleit, BSc, MBChB, MRCP, PhD, discusses the importance of patient-reported outcomes in the phase 1 GARNET trial in advanced or recurrent mismatch repair deficient/microsatelite instability-high endometrial cancer.