Trending News on Targeted Oncology, Week of December 4, 2020

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.