Kristi Rosa

December 23, 2020 - The FDA has granted an orphan drug designation to the mismatched, double-stranded RNA molecule rintatolimod for the treatment of patients with pancreatic cancer.

December 23, 2020 — Although SGX942 was found to induce clinically meaningful reductions in severe oral mucositis vs placebo in patients with head and neck cancer, the benefit failed to reach statistical significance, thus missing the primary end point of the phase 3 DOM-INNATE study.

December 23, 2020 - Entrectinib continued to demonstrate clinically meaningful, durable responses with a manageable toxicity profile in patients with NTRK fusion–positive sarcoma.

December 23, 2020 - The FDA has updated the prescribing information for ibrutinib to include safety and efficacy data for the agent in combination with rituximab in the treatment of patients with Waldenström macroglobulinemia.

December 22, 2020 — Intravesical Bacillus Calmette-Guerin in combination with N-803 was found to induce a complete response rate of 72% in patients with non-muscle invasive bladder cancer in high-risk carcinoma in situ disease, meeting the primary end point of the phase 2/3 QUILT 3.032 trial.

The small interfering RNA therapeutic STP705 has been found to induce high rates of histological clearance with a favorable toxicity profile in patients with squamous cell skin cancer.

December 22, 2020 — The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.

December 21, 2020 - Rucaparib was found to result in a statistically significant improvement in progression-free survival compared with chemotherapy in patients with BRCA-mutant ovarian cancer who had previously received 2 or more lines of chemotherapy.

December 21, 2020 — The addition of gilteritinib to azacitidine failed to significantly improve overall survival vs azacitidine alone in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who were not eligible for intensive induction chemotherapy, failing to meet the primary end point of the LACEWING trial.

December 21, 2020 - Cabozantinib was found to significantly improve progression-free survival compared with placebo in patients with dedifferentiated thyroid cancer who are refractory to radioiodine and have progressed following up to 2 prior VEGF-targeted treatments.

December 21, 2020 - The submission of a biologics license application to the FDA has been initiated for JZP-458 for use as a component of a multiagent chemotherapy regimen in the treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.

December 18, 2020 - The FDA has granted Emergency Use Authorization to the second vaccine to prevent coronavirus disease 2019 infection.

December 18, 2020 - The FDA has approved ponatinib for the treatment of patients with chronic-phase chronic myeloid leukemia that is resistant or intolerant to at least 2 prior kinase inhibitors.

December 18, 2020 - The FDA has approved osimertinib for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

December 18, 2020 - The FDA has approved the oral gonadotropin-releasing hormone receptor antagonist relugolix as a treatment for patients with advanced prostate cancer.

December 18, 2020 - The FDA has approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 previous therapy.

December 18, 2020 - A supplemental new drug application has been submitted to the FDA for avapritinib for use as a treatment in adult patients with advanced systemic mastocytosis.

December 17, 2020 - The FDA’s Vaccines and Related Biological Products Advisory Committee has voted 20-0 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine mRNA-1273.

December 17, 2020 - The FDA has approved rituximab-arrx, a biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

December 17, 2020 - The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment in patients with locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.

December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.

December 16, 2020 - A new drug application has been submitted to the FDA for sotorasib for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, after at least 1 previous systemic therapy.

December 16, 2020 - The FDA has approved margetuximab-cmkb plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.

December 16, 2020 - The combination of motixafortide plus pembrolizumab and chemotherapy was found to result in a substantial improvement in overall survival, progression-free survival, and overall response rate when used as a second-line treatment in patients with stage IV pancreatic ductal adenocarcinoma.

December 16, 2020 - Eric P. Winer, MD, FASCO, 2019 OncLive Giants of Cancer Care® recipient in Breast Cancer, has been elected to serve as the president of ASCO for the 2022-2023 term, and will assume the president-elect position during the 2020 ASCO Annual Meeting.

December 16, 2020 - Pembrolizumab/lenvatinib has significantly improved survival and responses compared with chemotherapy in patients with advanced endometrial cancer who have received previous systemic treatment.

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.