Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The FDA has issued a complete response letter to Athenex, Inc. stating that it will not, at this time, approve the new drug application for oral paclitaxel in combination with encequidar for the treatment of patients with metastatic breast cancer.
The FDA has approved melphalan flufenamide for use in combination with dexamethasone in the treatment of select adult patients with relapsed/refractory multiple myeloma.
Natural killer cells can offer several advantages over T cells for CAR therapy in that the former uses both a CAR dependent and independent mechanism for tumor eradication, has better safety, and off-the-shelf feasibility—all at a potentially lower cost.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.
The FDA has granted a breakthrough therapy designation to cabozantinib as a potential therapeutic option for patients with differentiated thyroid cancer that has progressed after previous therapy and who are refractory to radioactive iodine.
February 24, 2021 - The CAR T-cell product KTE-X19 continues to demonstrate durable clinical benefit in patients with relapsed/refractory mantle cell lymphoma, with an overall response rate of 92%.
February 24, 2021 - The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.
Feburary 23, 2021 — The addition of the anti-CD20 monoclonal antibody ublituximab to ibrutinib led to a statistically higher overall response rate over ibrutinib alone with acceptable safety in patients with relapsed/refractory, high-risk, chronic lymphocytic leukemia.
February 23, 2021 - The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.
February 22, 2021 - The FDA has granted a fast track designation to the DNA-mediated interleukin-12 immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer.
February 22, 2021 - The FDA has granted priority review to a supplemental new drug application for ruxolitinib for use in adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease.
February 22, 2021 - The FDA has approved cemiplimab-rwlc monotherapy for use in the frontline treatment of patients with advanced non–small cell lung cancer with a PD-L1 expression level of 50% or higher.
AstraZeneca has voluntarily withdrawn durvalumab from the US market for the treatment of adult patients with locally advanced or metastatic bladder cancer.
February 19, 2021 - The National Comprehensive Cancer Network has issued guidelines for the management of children with a rare type of kidney cancer referred to as Wilms Tumor, or nephroblastoma.
February 18, 2021 - Single-agent cemiplimab has been found to result in a significant improvement in overall survival and progression-free survival versus chemotherapy in patients with advanced non–small cell lung cancer who had a PD-L1 expression of at least 50%.
February 18, 2021 - Two supplemental biologics license applications have been submitted to the FDA for enfortumab vedotin-ejfv to convert the agent’s accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer who had received prior treatment with a PD-1/PD-L1 inhibitor and are not eligible for cisplatin.
February 18, 2021 — The use of next-generation sequencing demonstrated that 34% of patients with sarcoma had potentially actionable mutations.
February 17, 2021 - An independent data monitoring committee has concluded that the phase 3 OlympiA trial examining olaparib crossed the superiority boundary for its primary end point of invasive disease-free survival in patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer.
February 17, 2021 - The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
February 17, 2021 — The FDA has accepted a supplemental new drug application of zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.
February 16, 2021 - The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy
February 15, 2021 - The combination of lurbinectedin and irinotecan following relapse on frontline treatment was found to induce promising antitumor activity in patients with small cell lung cancer.
February 12, 2021 - The FDA has approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
February 12, 2021 - The European Commission has granted marketing authorization to tucatinib for use in combination with trastuzumab and capecitabine in the treatment of adult patients with HER2-positive, locally advanced or metastatic breast cancer who have previously received at least 2 HER2-targeted regimens
February 11, 2021 - First-line treatment with immune checkpoint inhibitor–based regimens could be linked with an improvement in overall survival versus select targeted therapies in patients with metastatic non–clear cell renal cell carcinoma.
February 10, 2021 - A biologics license application has been submitted to the FDA for the accelerated approval of the antibody-drug conjugate tisotumab vedotin for use in patients with recurrent or metastatic cervical cancer that has progressed on or following chemotherapy.
February 10, 2021 - Treatment with the investigative gene cell therapy betibeglogene autotemcel led to durable transfusion independence in 87% of pediatric patients less than 18 years of age with transfusion-dependent beta-thalassemia with a median average hemoglobin of 11.3 g/dL.
February 9, 2021 - The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.
February 9, 2021 - The European Commission has granted a full marketing authorization for fedratinib for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocytopenia myelofibrosis who have not received JAK inhibitors or who have received ruxolitinib.
February 9, 2021 - The FDA has granted breakthrough therapy designations to asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who received prior treatment with 2 or more TKIs, and for adult patients with Ph-positive CML in chronic phase whose tumors harbor the T315I mutation.
