Kristi Rosa

December 15, 2020 - The FDA has granted a fast track designation to devimistat for the treatment of patients with acute myeloid leukemia.

December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2–based regimens.

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.

December 14, 2020 — A link between tumor growth rate and clinical outcomes was established in patients with sarcoma who received treatment with immunotherapy or targeted therapy.

December 11, 2020 - The FDA has authorized the first vaccine for the prevention of coronavirus disease 2019.

December 11, 2020 - The addition of 1 year of palbociclib to endocrine therapy failed to improve invasive disease-free survival in patients with hormone receptor–positive, HER2-negative breast cancer who are at high risk of relapse following neoadjuvant chemotherapy.

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 FDA's Vaccines and Related Biological Products Advisory Committee has voted 17-4 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine BNT162b2.

December 10, 2020 - The antibody-drug conjugate sacituzumab govitecan was found to induce clinical benefit over physician’s choice of therapy in patients with metastatic triple-negative breast cancer, irrespective of Trop-2 expression; however, greater efficacy was observed in those who had a medium or high Trop-2 score.

December 10, 2020 — The addition of ribociclib to endocrine therapy continued to significantly improve overall survival and delay subsequent chemotherapy compared with placebo, irrespective of endocrine partner in patients with hormone receptor–positive, HER2-negative breast cancer.

December 9, 2020 - Follow-up circulating tumor cell assessments were confirmed to strongly predict overall survival outcomes in patients with metastatic breast cancer, when performed at a median of 29 days following treatment initiation.

The antibody-drug conjugate TRPH-222 demonstrated early signs of efficacy with favorable tolerability at higher dose levels in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

December 8, 2020 - The FDA has granted a breakthrough therapy designation to sotorasib for use as a potential treatment in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.

December 7, 2020 - The addition of ixazomib to lenalidomide and dexamethasone resulted in a clinically meaningful 13.5-month improvement in the median progression-free survival of elderly patients with transplant-ineligible newly diagnosed multiple myeloma, although it did not reach statistical significance.

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was found to yield clinically meaningful improvements in the quality-of-life of triple-class exposed patients with relapsed/refractory multiple myeloma.

December 6, 2020 - The first-of-its-kind FcRH5xCD3 bispecific antibody cevostamab demonstrated a manageable safety profile with an overall response rate of 53% in heavily pretreated patients with relapsed/refractory multiple myeloma who received active doses.

December 6, 2020 — The off-the-shelf DuoBody® IgG4 PAA binding antibody talquetamab has elicited a high response rate with a tolerable safety profile in heavily pretreated patients with relapsed/refractory multiple myeloma.

December 6, 2020 — Patients with hematologic malignancies are at increased risk for significant morbidity and mortality from coronavirus disease 2019, and the risk of death appeared to be greatest in those who were older, had more severe infection, a poorer prognosis, or who decided to forego intensive treatment

A novel combination comprised of the oral, selective RARα agonist SY-1425 and azacitidine demonstrated clinical activity with acceptable tolerability in a heavily pretreated population of patients with relapsed/refractory acute myeloid leukemia with RARA positivity.

December 5, 2020 - Ruxolitinib was found to elicit a significantly higher overall response rate, a substantially greater improvement in failure-free survival, and greater symptom improvement versus best available therapy in patients with chronic graft-versus-host disease with an inadequate response to corticosteroids.

December 4, 2020 - The completion of the biologics license application for balstilimab in the treatment of patients with recurrent or metastatic cervical cancer has been delayed to the first half of 2021.

December 3, 2020 — The survivin-targeted T-cell therapy DPX-Survivac, when used in combination with intermittent low-dose cyclophosphamide, prolonged clinical benefit with promising tolerability in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer.

December 3, 2020 - Lurbinectedin plus doxorubicin failed to significantly improve overall survival versus physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine in patients with small cell lung cancer who progressed after 1 previous platinum-containing line of treatment, missing the primary end point of the phase 3 ATLANTIS trial.

December 3, 2020 — A biologics license application has been submitted to the FDA for the EGFR-MET bispecific antibody amivantamab for the treatment of patients with metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations who have progressed on or following a platinum-based chemotherapy.

December 2, 2020 - Patients with high-grade Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer who responded to the investigational gene therapy nadofaragene firadenovec had a lower rate of cystectomy and delayed time to cystectomy compared with those who did not respond.

December 1, 2020 - The FDA has approved pralsetinib for the treatment of select patients with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

December 1, 2020 - The FDA has approved Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.

December 1, 2020 — The FDA has granted a fast track designation to irinotecan liposome injection as second-line monotherapy option for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.