News

Zanubrutinib has been approved by the FDA to treat adult patients with Waldenström macroglobulinemia.

Adjuvant giredestrant is being evaluated in comparison with other endocrine therapies for the treatment of ER-positive, HER2-negative, early breast cancer.

P-PSMA-101, an autologous CAR-T product for the treatment of metastatic castrate-resistant prostate cancer, produces a durable response.

In an interview with Targeted Oncology, Ghassan K. Abou-Alfa, MD, discusses the efficacy of tislelizumab in HCC in greater detail, along with safety and the agent’s mechanism of action. 

Here is a look back FDA happenings from July 2021.

The FDA has approved pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. 

In an interview with Targeted Oncology, Marc Ernstoff, MD, discussed the significance of the SITC clinical practice guideline for managing immune-related adverse events.

The high prevalence of bone metastases in non–small cell lung cancer led 2 institutions to investigate how these metastases impact survival in patients treated with immune checkpoint inhibitors.

LP-184 is moving forward in the course of development and was granted an orphan drug designation by the FDA.

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center discusses the results of the phase 2 study of tislelizumab in patients with unresectable hepatocellular carcinoma.

For patients with neuroendocrine tumors, the chances of dying of cancer were higher than dying of other causes, but mortality largely varies by primary tumor site.

Following the successful completion of the phase 1b analysis, the study of devimistat in combination with gemcitabine and cisplatin in biliary tract cancer has moved on to phase 2.

Adding berzosertib, a novel ataxia telangiectasia and Rad3-related inhibitor drug, to standard-of-care chemotherapy does not extend progression-free survival for patients with metastatic urothelial cancer.

Sacituzumab goveitecan has been administered to the first time in a patient with metastatic or locally advanced unresectable urothelial carcinoma as part of the phase TROPICS-04 study.

In an interview with Targeted Oncology™, Eric S. Nadler, MD, discusses IMpower133’s real-world implication and the effects immunotherapy has had on the ES-SCLC space.

Camrelizumab when used in combination with gemcitabine, and cisplatin has shown potential as a new standard of care for the frontline treatment of nasopharyngeal carcinoma.

Atezolizumab plus nab-paclitaxel will no longer be a treatment option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer following Roche's withdraw of the indication from the United States market.

Tycel Jovelle Phillips, MD, discusses the design of a phase 1 study looking at venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma.

A new cell therapy containing autologous tumor-infiltrating lymphocytes followed by nivolumab maintenance is both safe and clinically active in patients with metastatic non-small cell lung cancer.

In an interview with Targeted Oncology™, study co-investigator Yousef Zakharia, explained the background and results of the DUART study.

The long-term efficacy of autologous hematopoietic stem cell transplantation in mantle cell lymphoma has been evaluated and confirmed 15 years later.

In an Interview with Targeted Oncology, Debasish Tripathy, MD, discusses the triplet regimen for HER2+ breast cancer with leptomeningeal metastases in greater detail along with its broader clinical applications.

To accompany a newly approved targeted therapy for IDH1-mutated cholangiocarcinoma, the Oncomine Dx Target Test has been approved as a companion diagnostic.

In a compassionate use study, leronlimab demonstrated major improvement in survival outcomes in patients with metastatic triple-negative breast cancer.

Roxadustat appears to be a well-tolerated, effective treatment for chemotherapy-induced anemia.

In an interview with Targeted Oncology™, lead study author Elisa Agostinetto, MD, of the Istituto Clinico Humanitas in Rozzano, Milan, Italy, discussed the accuracy of PREDICT+ in HER2-positive breast cancer in greater detail and its clinical implications.

Lori Wirth, MD, discusses the future of selpercatinib in RET-altered thyroid cancers. 

The FDA has accepted the biologics license application for tebentafusp and granted it priority review for the treatment of adult patients with HLA-A*02:01-positive metastatic uveal melanoma.

The FDA has approved iIvosidenib Tablets for the treatment of patients with IDH1-mutant cholangiocarcinoma.

Asciminib for the treatment of 2 chronic myeloid leukemia subgroups is now under FDA consideration for approval.