Gina Mauro

The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.

The FDA has granted an accelerated approval to loncastuximab tesirine (Zynlonta) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.

The FDA has granted a priority review designation to SH-111, a sterile injectable therapy, for the treatment of pediatric patients with T-cell leukemia.

The FDA has approved the VENTANA MMR RxDx panel as a companion diagnostic assay to determine eligibility for dostarlimab-gxly as a treatment for patients with advanced or recurrent endometrial cancer whose tumors are mismatch repair deficient.

The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.

The FDA has granted an accelerated approval to dostarlimab-gxly (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are mismatch repair deficient, as determined by an FDA-approved test.

Although the malignancy has an encouraging survival rate, it is necessary to be aware of the complexity of nasopharyngeal cancer.

The FDA granted a Regenerative Medicine Advanced Therapy designation to the allogeneic chimeric antigen receptor T-cell therapy as a potential treatment for patients with relapsed/refractory multiple myeloma.

The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.

As part of a resubmission plan for a biologics license application for omburtamab in pediatric patients with central nervous system and leptomeningeal metastasis from neuroblastoma, Y-mAbs, the manufacturer of the B7-H3–targeting monoclonal antibody, announced that it is collecting additional granularity data requested by the FDA and anticipates submitting them to the regulatory agency by the end of April 2021.

Reattaching the greater trochanter to the proximal femur endoprosthesis did not show an improvement in Trendelburg gait or reliance on an assistive ambulatory device vs a soft tissue–only abductor repair in patients with bone cancers.

AFM13, an innate cell engager, demonstrated an objective response rate of 100% in adult patients with CD30-positive, relapsed/refractory Hodgkin lymphoma.

The combination of the selective MCL-1 inhibitor AMG 176 plus gilteritinib was found to synergistically target preclinical models of FLT3 internal tandem duplication–mutated acute myeloid leukemia.

Nivolumab in combination with paclitaxel showed clinical activity and a manageable safety profile when used as second-line therapy for patients with Epstein-Barr virus–related, microsatellite instability–high/mismatch repair deficient or PD-L1–positive advanced gastric cancer.

The combination of copanlisib and rituximab was associated with a 48% reduction in the risk of disease progression or death compared with rituximab plus placebo in patients with relapsed indolent non-Hodgkin lymphoma.

The CDK9 inhibitor voruciclib demonstrated early activity as a single agent in KRAS-mutant cancer cell lines, and synergistically inhibited growth of KRAS-mutant cancers when used in combination with sotorasib and adagrasib in preclinical models.

A supplement biologics license application has been submitted to the FDA for brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

More patients with stage III non–small cell lung cancer received sequential chemoradiation and delayed the time to durvalumab treatment in a real-world setting compared with those enrolled on the phase 3 PACIFIC trial.

The FDA has approved idecabtagene vicleucel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The half-life extended, DLL3-targeting bispecific T-cell engager AMG 757 demonstrated early signals of efficacy and a favorable safety profile in patients with small cell lung cancer.

The exploration of mirvetuximab soravtansine as a potentially efficacious treatment in patients with advanced, high-grade, platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor–alpha expression continues with the ongoing, single-arm, phase 3 SORAYA trial.

Intravenous cetirizine showed comparable efficacy to IV diphenhydramine for the prevention of infusion reactions in patients with cancer who are undergoing treatment with an anti-CD20 antibody or paclitaxel.

José Baselga, MD, PhD, a breast cancer pioneer and executive vice president of oncology R&D at AstraZeneca, passed away on Sunday at the age of 61.

Anthracyclines and taxanes remain a backbone in the early-stage setting of triple-negative breast cancer as further evaluations of immunotherapy in the neoadjuvant and adjuvant settings needs to be conducted—efforts that will continue to shape the treatment paradigm.