Trending News on Targeted Oncology, Week of December 4, 2020
A review of the trending news in oncology online for the week of December 4, 2020, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.
The week of December 4, 2020, was a busy week for the FDA, with several newly-approved indications, as well as a number of designations that were granted to various treatments for patients with solid tumors and hematologic malignancies. To wrap up the end of November 2020, which saw 4 new FDA approvals within the month, the FDA granted a Breakthrough Therapy designation in biliary tract cancer, a Fast Track designation in acute myeloid leukemia, and a Priority Review designation for chronic graft-versus-host disease earlier this week.
These updates and others were trending this week:
First PSMA-Targeted PET Drug for Prostate Cancer Approved by FDA
The FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) as the first ever drug for positron emission tomography imaging of PSMA positive lesions in men with prostate cancer.
FDA Approves Pralsetinib for RET+ Thyroid Cancers
The FDA has approved pralsetinib (Gavreto) for the treatment of adult and pediatric patients who are 12 years old or older with advanced or metastatic RET-mutant medullary thyroid cancer and require systemic therapy. The agent is also indicated for patients who have RET fusion–positive thyroid cancer and require systemic therapy and who are refractory to radioactive iodine, if appropriate.
FDA Grants Priority Review to Infigratinib for the Treatment of Cholangiocarcinoma
The FDA has accepted a New Drug Application for the oral FGFR1-3 selective inhibitor, infigratinib (formerly BGJ398) and granted it Priority Review for the treatment of patients with cholangiocarcinoma.
FDA Grants Priority Review to Belumosudil for Chronic Graft-Versus-Host Disease
The FDA accepted the New Drug Application (NDA) from belumosudil (KD025) and granted it a Priority Review designation for the treatment of patients with chronic graft-versus-host disease.
FDA Grants Fast Track Designation to Onivyde in Small Cell Lung Cancer
The FDA has granted a Fast Track designation to the irinotecan liposome injection (Onivyde) as a potential treatment option for patients with small cell lung cancer who progressed following a first-line platinum-based regimen.
Exploring PSMA Therapies in Prostate Cancer
Declan Murphy, MD, of the Peter MacCallum Cancer Centre, discusses the current interest in using PSMA, following the FDA’s approval of Gallium 68 PSMA-11, which marks the first ever drug for PET imaging of PSMA-positive lesions in men with prostate cancer.
Case Based Peer Perspectives: A 66-Year-Old Man With Gastric Carcinoma
Bassel El-Rayes, MD, of Winship Cancer Institute of Emory University, reviews the case of a 66-year old man with gastric carcinoma and discusses the disease from diagnosis to unmet needs.
Special Feature: COVID-19
Protocol Filed With FDA for Phase 2 Trial of Leronlimab to Treat Long-Hauler Symptoms of COVID-19
A protocol has been filed with the FDA for a phase 2 clinical trial aimed to evaluate leronlimab (PRO 140) as treatment of patients with COVID-19 who are suffering from long-hauler symptoms.
Therapy Type and Site of Metastases Factor into HR+, HER2+ mBC Treatment
December 20th 2024During a Case-Based Roundtable® event, Ian Krop, MD, and participants discussed considerations affecting first- and second-line treatment of metastatic HER2-positive breast cancer in the first article of a 2-part series.
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Ilson Examines Chemoimmunotherapy Regimens for Metastatic Gastroesophageal Cancers
December 20th 2024During a Case-Based Roundtable® event, David H. Ilson, MD, PhD, discussed the outcomes of the CheckMate 649, CheckMate 648, and KEYNOTE-859 trials of chemoimmunotherapy regimens in patients with upper GI cancers.
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Navigating ESR1 Mutations in HR-Positive Breast Cancer With Dr Wander
October 31st 2024In this episode of Targeted Talks, Seth Wander, MD, PhD, discusses the clinical importance of ESR1 mutations in HR-positive metastatic breast cancer and how these mutations influence treatment approaches.
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Advancing Neoadjuvant Therapy for HER2+ Breast Cancer Through ctDNA Monitoring
December 19th 2024In an interview with Targeted Oncology, Adrienne Waks, MD, provided insights into the significance of the findings from the DAPHNe trial and their clinical implications for patients with HER2-positive breast cancer.
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