Kristie L. Kahl

The agency approved the supplemental new drug application to include the first-line treatment of adult patients with metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

The potential to identify occult prostate cancer and accurately characterize disease burden was observed with the novel prostate specific membrane antigen (PSMA)–targeted radiopharmaceutical for PET imaging technique.

Findings from a poster presentation at the 2021 Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR suggest the feasibility of successful vaccinations against coronaviruses in patients with hematologic malignancies following stem cell transplant.

Results from the phase 2/3 KEYNOTE-010 trial continue to favor pembrolizumab, including key survival end points.

“We’re hearing about other antibody-drug conjugates, other agents in hormone receptor–positive metastatic disease, and the next generation of drugs that we’ll be using to treat our patients.”

Investigators aimed to evaluate additional end points from the phase 3 RxPONDER trial in women with hormone receptor–positive, HER2-negative, lymph node–positive breast cancer.

In this trial, investigators launched RxPONDER, in which 5015 patients with a recurrence score between 0 and 25 were randomized to endocrine therapy alone or chemotherapy followed by endocrine therapy.

When compared with chemotherapy, patients with microsatellite-instability high/mismatch repair deficient metastatic colorectal cancer saw significant improvement in progression-free survival with the frontline use of pembrolizumab monotherapy, while demonstrating superior safety.

The FDA issued an emergency use authorization for the second coronavirus 2019 disease vaccine, Moderna COVID-19 Vaccine, to be distributed in the U.S. for use in individuals 18 years of age and older.

The FDA approved the supplemental new drug application for ponatinib (Iclusig) to treat patients with chronic-phase chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

The agency authorized use of the first coronavirus disease 2019 vaccine to prevent the disease caused by severe acute respiratory syndrome coronavirus 2 in individuals 16 years of age and older.

Behavioral interventions were found to help young breast cancer survivors in reducing their depressive symptoms.

Women who were younger, diagnosed with breast cancer, and received chemotherapy were reported to have a higher risk of new chronic controlled substance use following mastectomy with reconstruction.

The combination induced low rates of infusion-related reaction, and had a shorter administration duration, increasing convenience for patients and decreasing treatment burden, according to Meletios A. Dimopoulos, MD.

The procedure provided effective, long-term local control for patients with localized penile cancer, highlighting the need for a multidisciplinary approach to patient care.

Deep-learning algorithms could be used to alert pathologists to suspicious areas of cancer burden prior to clinical assessment, according to Nitin K. Yerram, MD.

The novel androgen receptor-signaling inhibitor led to negative repeat biopsies after 90 days of treatment among men with very-low risk to favorable intermediate risk prostate cancer on active surveillance.

A telemedicine Multidisciplinary Urologic Cancer Clinic at the University of Washington/Seattle Cancer Care Alliance conducted video visits, inducing high patient satisfaction, sparing substantial travel burden and providing individuals access to multidisciplinary urologic cancer care.

The company expects to complete the rolling submission of its biologics license application for ublituximab in combination with umbralisib in the first half of 2021.

The agency granted fast track designation to irinotecan liposome injection for patients with small cell lung cancer who progressed following a first-line platinum-based regimen.

The FDA granted accelerated approval to pralsetinib to treat with advanced or metastatic RET-mutant medullary thyroid cancer or RET fusion-positive thyroid cancer.

The agency approved the first PSMA-targeted PET imaging drug to treat men with prostate cancer.

The agent’s new drug application will be reviewed under the FDA’s Real Time Oncology Review pilot program and under Project Orbis.

The combination regimen demonstrated improved progression-free and overall survival in patients with previously untreated advanced RCC, according to results from the phase 3 CheckMate-9ER trial.

The agency approved the first and only immunotherapy treatment as a first-line therapy for adult patients with unresectable malignant pleural mesothelioma.

“The combination of cabozantinib and atezolizumab demonstrated encouraging clinical activity in previously untreated patients with advanced ccRCC,” said investigator Sumanta Kumar Pal, MD.

Treatment with a novel BiTE® immuno-oncology therapy showed a manageable safety profile with preliminary efficacy in patients with metastatic castration-resistant prostate cancer.

The PARP inhibitor reduced the risk for death by 31% in men with metastatic castration-resistant prostate cancer, compared with enzalutamide or abiraterone plus prednisone.

The FDA approved the first anti-BCMA therapy, belantamab mafodotin-blmf, to treat patients with relapsed/refractory multiple myeloma who have received 4 prior therapies.

The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.