News

The Biden Administration has announced a new model, the Enhancing Oncology Model, aimed at improving cancer care for Medicare and Medicaid patients and lowering health care costs.

Improvement in overall survival has been demonstrated with the combination of durvalumab and tremelimumab in patients with unresectable liver cancer treated in the phase 3 HIMALAYA study.

In the phase 3 TOPAZ-1 trial, the addition of durvalumab to standard-of-care chemotherapy achieved a statistically significant improvement in overall survival compared chemotherapy alone, meeting the study's primary end point.

The FDA has granted priority review to an approval application for mosunetuzumab for the treatment of patients with relapsed or refractory follicular lymphoma.

Rare pediatric disease designation has been awarded to paxalisib for the treatment of patients with atypical rhabdoid or teratoid tumors in rare and highly-aggressive childhood brain cancer.

Data from the phase 3 ASTRA study show that selumetinib does not induce a complete remission in patients with differentiated thyroid cancer.

Sam S. Chang, MD, MBA, discusses the research of N-803 in combination with BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer.

Cathy Eng, MD, FACP, FASCO, discusses the types of patients who should be tested for biomarkers in the anal cancer space.

In the RATIONALE 306 clinical trial, the combination of tislelizumab and chemotherapy achieved a 34% reduction in the risk of death in patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma with either high or low PD-L1 expression.

A look back at all of the FDA happenings of June 2022.

Duvelisib shows possibility of increased risk of death and serious side effects vs other medicines in patients with leukemia and lymphoma.

PT886 was granted orphan drug designation by the FDA for the treatment of patients with pancreatic cancer.

David Barrington, MD, discusses the key takeaways regarding the factors associated with variation of adjuvant treatments for patients with stage 1B, grade 3 endometrial cancer.

Andreas Saltos, MD, discusses the key takeaways of the phase 1/1b clinical trial exploring the use of binimetinib plus erlotinib in patients with non–small cell lung cancer harboring either KRAS or EGFR mutations.

In an interview with Targeted Oncology, Manali Kamdar, discussed the recent FDA approval of lisocabtagene maraleucel for the treatment of patients with relapsed or refractory large B-cell lymphoma, and how community oncologists should approach patient referrals and post-treatment care.

Botensilimab and balstilimab use in patients with microsatellite stable colorectal cancer showed strong durability and superior efficacy, according to expanded data from the phase 1b C-800 study

The FDA has granted fast track designation to belzupacap sarotalocan for the treatment of patients with non-muscle invasive bladder cancer. A phase 1 study is planned to launch in 2022.

A phase 1/1b monotherapy clinical trial of RMC-6236 for the treatment of patients with advanced solid tumors driven by a variety of RAS mutations has dosed its first patient.

Five-year data from the RESPONSE-2 study combined with prior RESPONSE study results show that there is an option for the roughly 40% of patients with polycythemia vera who become intolerant or resistant to hydroxyurea.

Findings from an analysis of the CAPTIVATE study imply that ibrutinib plus venetoclax may allow for effective subsequent retreatment with ibrutinib and/or venetoclax and enhance clinical benefit.

During an interview with Targeted Oncology, Gunther Koehne, MD, PhD, explained the need to get experts together and discuss the increased activity of new developments for hematologic malignancies.

The FDA has granted breakthrough therapy designation to talquetamab for the treatment of previously-treated adult patients with relapsed or refractory multiple myeloma based on positive results from the phase 1/2 MonumenTAL-1 study.

A partial clinical hold has been placed by the FDA on the phase 1/2 NUV-422-02 trial examining NUV-422 in solid tumors, including high grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer.

In a phase 1 clinical trial, treatment with GFH009 showed early signal s of efficacy in patients with advanced relapsed or refractory lymphoma and acute myeloid leukemia.

Eric S. Nadler, MD of Texas Oncology, discusses the real-world patient characteristics and treatment duration of the immunotherapy combination treatment of the IMpower133 trial in patients with extensive-stage small cell lung cancer.

Gilteritinib monotherapy reacts favorably and led to higher rates of composite complete remissions in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia who received prior midostaurin or sorafenib.

In an interview with Targeted Oncology™, Karen L. Reckamp, MD, discussed that limited options for patients with advanced NSCLC who are resistant to immune checkpoint inhibitor therapy. Reckamp also discusses how Lung-MAP research might play a hand in bringing new therapies in the future.

In patients with HER2-positive breast cancer, an investigational liquid biopsy was more favorable compared with needle biopsies, a study shows.

The FDA has granted approval lisocabtagene maraleucel for the treatment of adult patients with large B-cell lymphoma, with specific indications for patients with relapsed or refractory disease.