January 28, 2021 — Pembrolizumab in combination with chemotherapy continued to show improved overall survival and progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic nonsquamous non–small cell lung cancer.
January 26, 2021 - Novartis has signed a strategic collaboration agreement to in-license the PD-1 inhibitor tislelizumab from BeiGene, Ltd, in various markets outside of China.
January 26, 2021 - The European Commission has approved single-agent pembrolizumab for use in the frontline treatment of patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
January 25, 2021 - The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.
January 25, 2021 - The Japanese Ministry of Health, Labour and Welfare approved the BTK inhibitor acalabrutinib for use in adult patients with relapsed/refractory chronic lymphocytic leukemia, including small lymphocytic lymphoma
January 25, 2021 - The European Commission has approved avelumab for use as a frontline maintenance option in the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who did not progress after having received platinum-based chemotherapy.
January 22, 2021 — The Japan Ministry of Health, Labour and Welfare has approved the CAR T-cell therapy axicabtagene ciloleucel for use in the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.
January 20, 2021 - The antibody-drug conjugate trastuzumab deruxtecan has been granted conditional approval in the European Union for use as a single agent in the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more HER2-based regimens.
January 15, 2021 - Durvalumab has been approved in the European Union and the United Kingdom for a fixed-dose option of 1,500 mg every 4 weeks for use in patients with locally advanced, unresectable non–small cell lung cancer whose tumors have a PD-L1 expression of at least 1% and who have not experienced disease progression after platinum-based chemoradiation treatment.
January 14, 2020 — The National Medical Products Administration of China has accepted a supplemental new drug application for sintilimab injection for use in the second-line treatment of patients with squamous non–small cell lung cancer.
January 14, 2020 - The China National Medical Products Administration has approved tislelizumab for use in combination with 2 chemotherapy regimens in the frontline treatment of patients with advanced squamous non–small cell lung cancer.
James Gerson, MD, discusses how he navigates treatment selection for patients with CLL and exciting developments in the pipeline.
January 13, 2021 - Health Canada has approved the combination of ibrutinib and rituximab for use in patients with treatment-naïve chronic lymphocytic leukemia.
January 8th, 2021 - The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against nivolumab for use in patients with recurrent or metastatic head and neck squamous cell carcinoma who experienced disease progression during or after platinum-based chemotherapy.
January 6, 2021 — The oral small molecule inhibitor VS-6766, developed by Verastem Oncology, is now under investigation alone and in combination with the FAK inhibitor defactinib in a recently initiated, registration-directed, phase 2 trial in patients with recurrent low-grade serous ovarian cancer.
January 5, 2020 - A new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare for the oncolytic virus teserpaturev for use in the treatment of patients with malignant glioma.
January 4th, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the approval of amivantamab as a treatment for patients with metastatic non–small cell lung cancer that harbors EGFR exon 20 insertion mutations who have experienced disease progression following platinum-based chemotherapy.
January 4, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the use of sotorasib in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.
December 30, 2020 - The China National Medical Products Administration has approved surufatinib for the treatment of patients with non-pancreatic neuroendocrine tumors.
December 23, 2020 - The European Commission has approved the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, to be administered via a subcutaneous injection in the treatment of patients with early and metastatic HER2-positive breast cancer.
Othman Al-Sawaf, MD, discusses the limitations of continuous therapy administration in chronic lymphocytic leukemia.
December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.
Timothy Price, MBBS, DHthSc, FRACP, discusses the rationale to evaluate sotorasib in gastrointestinal cancers.
December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.
Circulating tumor DNA positivity identified patients with high-risk muscle-invasive urothelial cancer who were likely to derive improvements in disease-free survival and overall survival from adjuvant atezolizumab vs observation.
Nadia Harbeck, MD, PhD, discusses Ki-67 as a biomarker for identifying patients with high-risk early breast cancer who received treatment on the monarchE trial.
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.
