All Oncology News

The FDA has granted a priority review designation to a new drug application for mobocertinib for the treatment of adult patients with EGFR exon 20 insertion mutation–positive metastatic non–small cell lung cancer, as detected via an FDA-approved assay, who have received previous platinum-based chemotherapy.

Triaging individuals with the highest likelihood of cancer detection with their clinical indication and individual risk factors during periods of reduced capacity could be an efficient way of identifying the most cancers with the least examinations compared with a non–risk-based approach.

The FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in support of maintaining the indication of atezolizumab in combination with nab-paclitaxel as a treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors are PD-L1 positive.

After years of stagnation, the paradigm for treating patients with unresectable intermediate-stage or advanced hepatocellular carcinoma is starting to change as a result of novel strategies and evolving views of appropriate patient populations for systemic therapies.

The National Comprehensive Cancer Network® has added the CDK4/6 inhibitor trilaciclib to its Clinical Practice Guidelines in Oncology for small cell lung cancer as well as for supportive care for hematopoietic growth factors.

Michael Grunwald, MD, discusses the evolving landscape of cellular therapy in acute leukemias and key research efforts and hypotheses aimed at addressing ongoing challenges.

I-Mab Biopharma and ABL Bio, Inc set their sights on adding the bispecific antibody, TJ-CD4B, to the expanding armamentarium for patients with various types of advanced and metastatic solid cancers.

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.

Although chemotherapy is not likely to lose its place in the frontline treatment of patients with B-cell lymphomas, encouraging data from early-phase studies evaluating the use of targeted agents in combination with and without chemotherapy are capturing the interest of investigators in the field.

The CheckMate 274 trial may have captured attention during the 2021 Genitourinary Cancers Symposium, but immunotherapy is not the only promising approach under study in urothelial carcinoma.

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 development of novel therapies aimed at tumors with RET alterations in non-small cell lung cancer and thyroid cancers sets the stage for a future tumor-agnostic role for this molecularly targeted approach.

Current breast cancer screening practices in the Caribbean exclude the majority of the younger patient population, thereby leaving many cases of breast cancer undiagnosed.

Apalutamide plus androgen deprivation therapy maintained an overall survival advantage over placebo for a broad population of patients with metastatic castration-sensitive prostate cancer after nearly 4 years of median follow-up.

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’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

Natasha Garg, DO, discusses the impact of antiandrogens in the treatment of patients with nonmetastatic CRPC, shared advice for choosing among the available options, and projected what the future paradigm might look like.

With immunotherapy options expanding for patients with a range of gastrointestinal cancers to include combination strategies with chemotherapy, their use in the treatment course should come sooner rather than later for those with high PD-L1 expression.

Jason Zhu, MD, discusses the need to tailor therapy with androgen-deprivation therapy, radiation, and antiandrogen agents for men with pathologic and clinical node-positive prostate cancer.

William Gradishar, MD, discusses the phase 2 data evaluating the activity with IV cetirizine and its potential use in patients with breast cancer.

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.

Olwen Hahn, MD, discusses future research directions with tucatinib (Tukysa) in the treatment of patients with breast cancer.

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.

Sara A. Hurvitz, MD, can remember the exact moment she decided to become an oncologist. It was her first day at the University of Southern California School of Medicine, which she had entered in 1995 without a firm idea of what discipline she wanted to pursue.

Study supports launch of Phase I clinical trial to test a designer DNA agent — an antisense oligonucleotide that targets a gene called IRF4 — in patients with multiple myeloma