Kristi Rosa

The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

Nivolumab in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.

The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.

The mortality rate with COVID-19 appears to be higher in patients with cancer—especially those with lung cancer—compared with the general population, according to updated data released from several registries reported during the AACR Virtual Meeting on COVID-19 and Cancer, and several factors associated with mortality are beginning to emerge.

To date, no FDA-approved options are available for patients under the age of 12 with SR-aGVHD in the United States, underscoring a great unmet need.

The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.

The situation with the coronavirus-19 pandemic continues to rapidly evolve, but one thing is clear: this is much more than just the common cold.

The FDA has accepted a supplemental new drug application (sNDA) seeking approval for selinexor (Xpovio) for the treatment of patients with multiple myeloma following at least 1 previous line of therapy.

Efbemalenograstim alpha (F-627) has demonstrated strong and lasting benefit when used as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, meeting the primary and secondary end points of a phase 3 study.

The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab monotherapy as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma.

Dexamethasone, a corticosteroid traditionally used in cancer treatment, may be beneficial in treating patients with the novel coronavirus 2019 (COVID-19).

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma, according to Cellectis, the manufacturer of the product.

A new drug application (NDA) has been submitted to the FDA for pralsetinib (BLU-667) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion–positive thyroid cancers, according to an announcement from Blueprint Medicines, the developer of the drug.

The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.

The FDA has granted a priority review designation to a biologics license application (BLA) for the investigational, humanized monoclonal antibody naxitamab (Danyelza) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

A United States population-based outcome analysis of real-world patients with myelofibrosis who had discontinued ruxolitinib (Jakafi) demonstrated an increase in morbidity burden and identified the risk factors of survival outcomes, according to John O. Mascarenhas, MD.

Just as the situation with COVID-19 continues to rapidly evolve, the oncology community must actively adapt how they approach the treatment of their patients based on the information available, according to Balazs Halmos, MD, MS.

To hinder the rapid spread of COVID-19 across the globe, mandatory lockdowns have been put into place to encourage the practice of social distancing, explained Omid Hamid, MD; however, efforts to prevent close contact, and thus exposure to the virus, have also caused disruptions in access to care for patients with cancer.

Following significant progress made in the development of novel systemic therapies for patients with cancer, the role of surgery in oncology continues to evolve. To this end, ASCO has selected the refinement of surgical treatment of cancer as its Advance of the Year.

Despite the emergence of PARP inhibitors, antibody-drug conjugates (ADCs), and immunotherapy in the treatment of patients with triple-negative breast cancer (TNBC), more work is needed to propel further progress, according to Kevin Kalinsky, MD, MS.

Despite the approvals of targeted agents and immunotherapy in the treatment paradigm of metastatic melanoma, clinical trials remain the gold standard for patients with newly diagnosed disease, according to Anna C. Pavlick, DO.

Residual cancer burden (RCB) after neoadjuvant chemotherapy has been shown to be an accurate long-term predictor of disease recurrence and survival across all breast cancer subtypes, according to data from a large meta-analysis presented at the 2019 San Antonio Breast Cancer Symposium.

The FDA has approved 2 abbreviated new drug applications (ANDAs) for everolimus (Afinitor) tablets for the treatment of patients numerous malignancies.

New study results show that chemoimmunotherapy combination options provide an overall survival benefit to patients with stage IV nonsquamous NSCLC.

President Trump has announced he will be nominating Stephen M. Hahn, MD, FASTRO, to be the next commissioner of the FDA.

The frontline combination of nivolumab (Opdivo) and ipilimumab (Yervoy) showed a robust and durable clinical benefit in patients with metastatic colorectal cancer (mCRC) whose tumors are microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMR)—a population with a historically poor prognosis, said Heinz-Josef Lenz, MD, FACP.