News

In the phase 3 IMforte clinical trial, researchers are exploring lurbinectedin and atezolizumab as induction and maintenance therapy for patients with extensive-stage small cell lung cancer.

Since the start of the Oncology Care Model program in 2016, Florida Cancer Specialists and Research Institute has saved Medicare $140 million.

With an orphan drug designation from the FDA, INBRX-109 may be on track to become the first FDA-approved treatment for chondrosarcoma.

Zai Lab has announced new findings from the phase 3 PRIME trial showing efficacy in progression-free survival in patients with platinum-sensitive ovarian cancer.

The combination elicited a complete response in patient with cervical cancer and a partial response in a patient with ovarian cancer.

The FDA has decided not to approve plinabulin with granulocyte colony-stimulating factor for the prevention of chemotherapy-induce neutropenia until further research is conducted.

Thomas Powles, MD, MBBS, MRCP, discusses the safety profile of enfortumab vedotin in urothelial cancers as observed in the phase 3 urothelial cancerstrial.

The approval is based on the phase 2 PLEAIDES study, which found the agent had an ORR of 84.8%, with 82.5% of patients still responding after 9 months.

Here is a look back FDA happenings from November 2021.

The FDA has extended the review period of the new drug application for pacritinib as treatment of patients with myelofibrosis and severe thrombocytopenia.

Dana Chase, MD, discusses frontline therapy options for patients with advanced ovarian cancer.

Top-line results from the phase 3 SORAYA study show promise for mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer.

KB-0742 is currently being evaluated in a phase 1/2 clinical trial. The terminal half-life was found to be 24 hours.

Findings from the phase 3 OlympiA led to the filing of a supplemental new drug application for olaparib as adjuvant treatment of BRCA-mutated HER2-negative high-risk early breast cancer.

In an interview with Targeted Oncology, Ruben Niesvizky, MD, discussed current efficacy outcomes in multiple myeloma and how the introduction of the car-BIRD regimen may improve upon them.

Erika Hamilton, MD, discusses the mechanism of action of rebastinib, which is currently being explored in combination with weekly paclitaxel 1b/2 study of patients with platinum-resistant ovarian cancer.

Markus Joerger, MD, discussed the outcomes and prognostic factors of patients with cancer won contract COVID-19 in an interview with Targeted Oncology.

Efficacy signals have been shown in 100% of patients with metastatic prostate cancer treated with a new formulation of cabazitaxel.

After 40 years, a novel agent may be on the fast track to becoming the first drug to improve the standard of care for patients with metastatic colorectal cancer.

The TROPION-Breast01 study aims to enroll 700 patients to determine the safety and efficacy of datopotamab deruxtecan in patients with HR-positive, HER2-negative breast cancer.

A novel chimeric antigen receptor T-cell agent will now be developed in the United States following an orphan drug designation granted by the FDA.

Results from the phase 3 AGENT study are awaited after the FDA granted fast track designation to arfolitixorin for advanced colorectal cancer treatment.

Carole Miller, MD, discusses the REVEAL trial design, an observational study on mortality and causes of death in patients with polycythemia vera. 

The community oncology organization, Tennessee Oncology, reportedly saved Medicare $5 million between 2019 and 2020.

Milademetan, an MDM2-inhibitor, has already shown preliminary antitumor efficacy in solid tumors.

BNT111, an immunotherapy agent under investigation in a phase 2 study, has been granted fast track designation by the FDA.

Alexander Spira, MD, PhD, FACP, discusses the prognosis of patients with EGFR- exon 20 mutated non-small cell lung cancer.

The phase 1b KOMET-001 has been suspended while the developer of KO-539 and FDA investigate a serious safety event.

In an interview with Targeted Oncology™, Richard T. Silver, MD, discussed the role of interferon in the treatment of myeloproliferative neoplasm as well as the importance of the 3-year global MPN initiative being conducted by the MPN Research Foundation.

Phase 1b results indicate no benefit when chemotherapy is added to novel regimens for chronic lymphocytic leukemia.