Kristi Rosa

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.

February 8, 2021 - Prior exposure to anti-CD19 therapy did not impact response to the CAR T-cell therapy lisocabtagene maraleucel in patients with relapsed/refractory large B-cell lymphoma.

Over the past 2 decades, the field of EGFR-mutated non–small cell lung cancer has grown tremendously, but the influx of data and the recent regulatory approval of adjuvant osimertinib have raised several important questions to be addressed to ensure that the optimal treatment approach is utilized.

February 5, 2021 - Following stem cell transplant or treatment with CAR T-cell therapies, patients with hematologic malignancies and coronavirus disease 2019 tend to have favorable outcomes, especially if they are diagnosed in complete remission and further out from their cell infusion.

February 5, 2021 - The FDA has granted an accelerated approval to umbralisib for the treatment of select patients with relapsed/refractory marginal zone lymphoma and relapsed/refractory follicular lymphoma.

February 5, 2021 - The FDA has approved lisocabtagene maraleucel for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.

February 5, 2021 - Durvalumab failed to improve overall survival over the EXTREME chemotherapy regimen in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with tumors expressed high levels of PD-L1, missing a primary end point of the phase 3 KESTREL trial.

February 5, 2021 - The potent CDK9 inhibitor zotiraciclib, when used in combination was temozolomide, was found to induce clinically meaningful efficacy with a tolerable safety profile in patients with recurrent, high-grade gliomas.

February 4, 2021 - In response to the coronavirus disease 2019 pandemic, investigators have turned to tried-and-true cancer drugs to see whether they can be used to combat the virus.

February 4, 2021 — The Israeli Ministry of Health has approved selinexor for the treatment of patients with multiple myeloma or diffuse large B-cell lymphoma.

February 4, 2021 - The China National Medical Products Administration has granted a conditional approval to gilteritinib for use in adult patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation detected by a validated test.

February 3, 2021 - Recent progress made with messenger RNA vaccines has led to amplified protein translation, stronger modulation of immunogenicity, and improved delivery, which has all contributed to an evolution in the application of these products in the field of cancer.

February 3, 2021- The FDA has granted an accelerated approval to tepotinib for adult patients with metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

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.