Kristi Rosa

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.

January 14, 2021 - The FDA has approved crizotinib for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma.

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.

January 13, 2021 — The FDA has granted an orphan drug designation to the BCMA-targeted trispecific T-cell activating recombinant protein construct as treatment for patients with multiple myeloma.

January 13, 2021 - Health Canada has approved the combination of ibrutinib and rituximab for use in patients with treatment-naïve chronic lymphocytic leukemia.

January 12, 2021 - Palbociclib in combination with endocrine therapy failed to result in a statistically significant improvement in progression-free survival over capecitabine in patients with hormone receptor–positive metastatic breast cancer who were resistant to aromatase inhibitors.

January 11, 2021 - The FDA has granted fast track designations to cavrotolimod for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma that is refractory to previous PD-1/PD-L1 blockade.

January 11, 2021 — The FDA has granted an orphan drug designation to the novel intratumoral immunotherapy agent PVSRIPO for the treatment of patients with advanced melanoma, specifically those with stage IIIB-IV disease.

January 11, 2021 - Larotrectinib was found to induce a high response rate with long durability and improve survival in patients with TRK-positive sarcomas, according to results from an analysis of 3 clinical trials.

January 8, 2021 — The combination of osimertinib plus bevacizumab failed to result in a statistically significant improvement in progression-free survival versus osimertinib alone in patients with advanced lung adenocarcinoma that harbored an EGFR T790M mutation.

January 8, 2021 - The FDA has approved a supplemental new drug application to add overall survival and other secondary end point data from the phase 3 ARAMIS trial to the prescribing information for darolutamide for the treatment of patients with nonmetastatic prostate cancer.

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 8, 2021 — The FDA has granted a fast track designation to zenocutuzumab for the treatment of patients with metastatic solid tumors that harbor NRG1 gene fusions and have progressed on standard-of-care treatment.

January 7th, 2021 - The addition of eganelisib to nivolumab was found to elicit encouraging responses and improve progression-free survival compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer.

January 7, 2020 - The FDA has approved the request submitted by Moleculin Biotech, Inc. for rare disease designations to be granted their drug candidate WP1066, an agent that appears to directly elicit tumor cell death and rouse the immune system to eliminate tumors.

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 6, 2020 - The FDA has deferred action on the biologics license application for the proposed bevacizumab biosimilar MYL-1402O.

January 5th, 2021 -The FDA has granted a fast track designation to the investigational antibody-drug conjugate ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.