Kristi Rosa

February 3, 2021 - Oral endoxifen, when delivered during the “window of opportunity” between diagnosis of breast cancer and surgery, resulted in a 74% average reduction in Ki-67 and Ki-67 levels lower than 25% at the time of surgery.

February 2, 2021 - The time to treatment deterioration for symptoms such as cough, dyspnea, and pain in the chest was found to be comparable between treatment-naïve patients with ALK-positive non–small cell lung cancer who received lorlatinib versus crizotinib.

February 1, 2021 — Targeted circulating tumor DNA methylation marker panels possess the potential for early blood-based detection of lung cancer with a high sensitivity and specificity.

February 1, 2020 - The European Medicines Agency’s Committee of Medicinal Products for Human Use has recommended a label expansion for pembrolizumab for use as a single agent in adult and pediatric patients aged 3 years and older with relapsed/refractory classical Hodgkin lymphoma for whom autologous stem cell transplant has failed or following at least 2 previous therapies when ASCT is not an option.

January 29, 2021 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for selinexor for use in combination with dexamethasone in the treatment of select adult patients with refractory multiple myeloma.

January 29, 2021 - Adjuvant osimertinib was found to improve disease-free survival in patients with EGFR-mutated non–small cell lung cancer, irrespective of previous adjuvant chemotherapy received or disease stage.

January 28, 2021 - The FDA has accepted a biologics license application for BAT1706, a proposed biosimilar to bevacizumab.

January 28, 2021 - The National Comprehensive Cancer Network and the American Cancer Society are collaborating with cancer organizations nationwide to promote the resumption of cancer screening and treatment during the coronavirus disease 2019 pandemic.

January 28, 2021 - The anti–PD-1 antibody tislelizumab was found to significantly improve overall survival compared with investigator’s choice of chemotherapy in the treatment of patients with advanced, unresectable, or metastatic esophageal squamous cell carcinoma.

As new findings emerge in the lung cancer treatment paradigm, innovative strategies have resulted in impressive central nervous system activity and encouraging responses with acceptable tolerability.

January 27, 2021 - The FDA has granted an orphan drug designation to the small molecule chemotherapeutic uttroside-B for use as a treatment in patients with hepatocellular carcinoma.

January 26, 2021 - The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma.

January 26, 2021 - Acalabrutinib showed noninferior progression-free survival and a significantly lower incidence of atrial fibrillation versus ibrutinib in patients with high-risk chronic lymphocytic leukemia.

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 FDA has approved the combination of nivolumab plus cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma.

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 21, 2021 - The FDA has granted priority review to a biologics license application for retifanlimab for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who were intolerant of or who had progressed on platinum-based chemotherapy.

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.

The FDA has granted priority review to a supplemental biologics license application for nivolumab for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation treatment.

January 20, 2021 - The FDA has granted a priority review to a supplemental biologics license application for nivolumab in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

January 19, 2021 - The FDA’s Center for Devices and Radiological Health has granted premarket approval to diagnostic breast cancer imaging technology developed by Seno Medical Instruments to assist in the differentiation between benign and malignant breast lesions in patients.

January 19, 2021 — The FDA has granted priority review to the biologics license application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

January 18, 2021 — The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer.

January 17, 2021 - Infigratinib was found to be associated with encouraging clinical activity with a manageable safety profile in patients with chemotherapy-refractory cholangiocarcinoma whose tumors harbor FGFR2 fusions.

January 15, 2021- The FDA has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a previous trastuzumab-based regimen.

January 15, 2021 - The FDA has approved daratumumab and hyaluronidase-fihj, 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.

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.