
November 30, 2020 - The European Medicines Agency has validated an application to review tepotinib for the treatment of adult patients with advanced non–small cell lung cancer that harbor MET exon 14 skipping alterations.

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Gina Mauro is your lead editorial contact for OncLive. She joined the company in 2015 and has held various positions on OncLive; she is also the on-air correspondent for OncLive News Network: On Location. Prior to joining MJH Life Sciences, she worked at Gannett as a full-time reporter with the Asbury Park Press. Email: gmauro@onclive.com

November 30, 2020 - The European Medicines Agency has validated an application to review tepotinib for the treatment of adult patients with advanced non–small cell lung cancer that harbor MET exon 14 skipping alterations.

November 30, 2020 - The FDA has approved the Sonalleve MR-guided high-intensity focused ultrasound (MR-HIFU) system for the treatment of patients with osteoid osteoma in the extremities.

The FDA has approved naxitamab-gqgk (Danyelza) for use in combination with granulocyte-macrophage colony-stimulating factor as a treatment for pediatric patients 1 year of age and older and adult patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior treatment.

Selinexor demonstrated a statistically significant improvement in progression-free survival compared with matching placebo in patients with advanced unresectable dedifferentiated liposarcoma, following at least 2 prior treatments.

The phase 3 SIENDO study, which is evaluating maintenance selinexor in endometrial cancer, has been recommended by the Data and Safety Monitoring Board to continue as previously planned without the need to add additional patients to the trial or amend the study protocol, following a prespecified interim futility analysis.

November 24, 2020 - The European Commission has approved nivolumab for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma following prior fluoropyrimidine- and platinum-based combination chemotherapy.

November 24, 2020 — The FDA has granted an orphan drug designation to devimistat for the treatment of patients with soft tissue sarcoma.

November 23, 2020 - The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes (MDS) to include the combination of decitabine and cedazuridine as a category 2a recommendation for the treatment of adult patients with intermediate- and high-risk MDS.

November 23, 2020 - Tebentafusp showed superiority in overall survival compared with investigator’s choice of therapy in patients with previously untreated metastatic uveal melanoma.

November 21, 2020 — Maintenance niraparib, when administered at an individualized starting dose, led to a 70% reduction in the risk of disease progression or death compared with placebo in Chinese patients with recurrent ovarian cancer who were in a complete or partial response to platinum-based chemotherapy.

Marilyn M. Bui, MD, PhD, highlights the importance of pathology in sarcoma and how it is the cornerstone of precision medicine.

November 16, 2020 - The combination of plinabulin and pegfilgrastim showed a statistically significant improvement in the rate of prevention of grade 4 neutropenia versus pegfilgrastim alone in patients with cancer undergoing chemotherapy.

November 13, 2020 - The combination of bempegaldesleukin and the PD-1 inhibitor nivolumab elicited a confirmed best overall response rate of 53% in efficacy-evaluable patients with metastatic melanoma.

November 13, 2020 - The combination of nivolumab and ipilimumab elicited an objective response rate of 25% and was found to be well tolerated in patients with advanced or unresectable angiosarcoma, according to cohort findings of the phase 2 DART trial.

November 12, 2020 — Pembrolizumab led to a 38% central nervous system response rate and was well tolerated in patients with leptomeningeal metastasis from solid tumors. However, the study was closed early due to poor accrual.

November 12, 2020 - The investigational PD-L1 inhibitor cosibelimab demonstrated durable and robust responses in patients with non–small cell lung cancer and cutaneous squamous cell carcinoma.

November 12, 2020 - In an effort to further improve outcomes without sacrificing tolerability, the combination of cabozantinib with pembrolizumab is being evaluated in patients with advanced melanoma in a phase 1b/2 study.

Recent research for effective therapies designed to target von Hippel-Lindau disease–associated renal cell carcinoma is pointing to a future with the paradigm that comprises immunotherapy, HIF-2α inhibitors, and potentially CDK4/6 inhibitors.

There is still a great deal to learn about the optimal use of BRAF-targeted therapy, as well as immunotherapy, in the adjuvant setting for patients with melanoma.

It was 5:00 PM on a Monday, and Andrew Pecora, MD, FACP, CPE, was just wrapping up his practice for the day when one of his nurses came to the door, asking if he could see one more patient.

With an estimated 5-year survival rate of 50% and an ongoing issue of resistance, next steps with immunotherapy in melanoma will focus on stratifying patients, personalizing therapy, and refining localized regimens.

The FDA has approved the FoundationOne CDx comprehensive genomic test as a companion diagnostic for larotrectinib (Vitrakvi) to identify patients with NTRK1/2/3 gene fusions across all solid tumors.

The investigational wholly-owned allogeneic CAR T-cell therapy CTX110 demonstrated dose-dependent efficacy and responses in patients with relapsed/refractory CD19-positive B-cell malignancies.

R. Lor Randall, MD, FACS, highlights the various data presented at the annual MSTS meeting and their implications for the future of sarcoma treatment.

Single-agent daratumumab as maintenance therapy improved progression-free survival compared with observation in patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant.

Brian T. Hill, MD, PhD, reflects on how the approval of CAR T-cell therapy has impacted clinical practice for his patients with MCL, ongoing research with practice-changing implications, and how MCL treatment has evolved during the coronavirus disease 2019 pandemic.

The FDA has granted a fast track designation to the investigational CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta inhibitor umbralisib for the treatment of adult patients with chronic lymphocytic leukemia.

Treatment with the CDK4/6 inhibitor trilaciclib prior to chemotherapy compared with placebo significantly reduced the need for supportive care interventions in the management of severe neutropenia and grade 3/4 anemia induced by chemotherapy in patients with extensive-stage small cell lung cancer.

As James K. McCloskey II, MD, begins the next chapter of his career as chief of the Division of Leukemia at John Theurer Cancer Center at Hackensack University Medical Center.

Mobocertinib elicited a 43% objective response rate and an 86% disease control rate in select patients with non–small cell lung cancer who have EGFR exon 20 insertion mutations.