The FDA announced several new approvals and indications for the treatment of patients with various types of cancer this week, which have all been included in April’s monthly round-up of FDA news in oncology. Data from the 2020 American Association for Cancer Research Annual Meeting were presented in the new virtual format that has been created in response to the travel restrictions and the need for social distancing caused by the global coronavirus disease 2019 (COVID-19) pandemic. Treatments for the novel COVID-19 remain under evaluation in several ongoing clinical trials.

These updates and others were trending this week:

FDA Approves Every-6-Week Pembrolizumab Dosage

On April 28, 2020, the FDA granted approval to a new dosage of pembrolizumab (Keytruda) at 400 mg administered every 6 weeks across all adult indications, whether the PD-1 inhibitor is used as either monotherapy or in combination with another therapy. The previously approved dose of pembrolizumab at 200 mg every 3 weeks will also be available.

FDA Approves Niraparib as Frontline Maintenance in Advanced Ovarian Cancer

On April 29, 2020, the FDA granted approval to niraparib (Zejula) as first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

Modest Updates to T-Cell Lymphoma Guidelines Reflect Changes in Regimens and Scans

Providing optimal care to all patients with cancer is a goal among all oncologists, but that objective is especially important in rare cancers. Community oncologists may infrequently encounter a patient with T-cell lymphoma in their practice; nonetheless, providing the latest information about the disease entity, as well as the appropriate workup, remains a key educational objective of the National Comprehensive Cancer Network.

Survival Improved With Frontline Cemiplimab as Treatment of Advanced NSCLC

Following recommendations from an Independent Data Monitoring Committee, a phase III clinical trial of the PD-1 inhibitor cemiplimab (Libtayo) for the treatment of patients with treatment-naïve, locally advanced or metastatic NSCLC who tested positive for PD-L1 in ≥50% of their tumor cells was stopped early. The trial achieved the primary end point of the study with significant improvement in overall survival (OS) compared with a platinum-doublet chemotherapy regimen.

Patients With Pretreated Sarcoma May Derive Benefit From Various Immunotherapy Combinations

Combination therapy strategies involving immune checkpoint inhibitors and a secondary agent have shown promise across sarcoma subtypes, according to analysis of clinical trial data that were presented at the ESMO Sarcoma & GIST Symposium 2020, held in Milan, Italy.

Targeted Oncology Case-Based Peer Perspectives

A 59-Year Old Woman With Stage IIIC Ovarian Cancer

Jubilee Brown, MD, of the Levine Cancer Institute, discussed the treatment approach for a patient with stage IIIC ovarian cancer.

Targeted Oncology Virtual Tumor Board:

Case 1: Early-Stage HER2+ Breast Cancer

Hope Rugo, MD, led a discussion with Adam Brufsky, MD, PhD; Ian Krop, MD, PhD; Evita Sadimin, MD; and Tiffany Traina, MD, who reviewed a clinical case and discussed an individualized treatment approach for the patient.

Special Feature: COVID-19 Updates

Close to 50 Patients Treated With Leronlimab for COVID-19, Many Recover

Leronlimab (PRO 140) demonstrated promising results in 49 patients with COVID-19 who received the CCR5 antagonist as treatment under the FDA’s emergency Investigational New Drug (eIND). Developer of the drug, CytoDyn, shared an update on the patients who have been treated; 54 patients have been approved by the FDA for the treatment under the eIND.

Phase III Trial of Pacritinib Initiated for Treatment of Severe COVID-19

The phase III PRE-VENT clinical trial of pacritinib which has primarily been explored in myelofibrosis, has been initiated for the treatment for hospitalized patients with severe COVID-19. The study will determine the effectiveness of pacritinib in preventing progression to acute respiratory distress syndrome and mechanical ventilation.

Managing Risk of COVID-19 in Geriatric Patients With Cancer

William Dale, MD, of the City of Hope, spoke with Targeted Oncology on his experience with caring for geriatric oncology patients during the COVID-19 pandemic.