News

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.

Results from a study of tazemetostat in patients with BAP1-inactivated malignant pleural mesothelioma show the feasibility of molecularly-stratified therapy for patients with relapsed or refractory disease.

Developers of elacestrant are seeking FDA approval of the agent for the treatment of patients with ER-positive/HER2-negative advanced or metastatic breast cancer.

A retrospective analysis of next-generation sequencing data showed that the presence of pathogenic POLE mutations correlate with clinical benefit in immune checkpoint inhibitor therapy.

In an interview with Targeted Oncology, Adam Weiner, MD, discussed molecular subtyping for prostate cancer based on basal and luminal cell-of-origin and how such research may impact the future of this space.

In an interview with Targeted Oncology, Leonard A. Kalman, MD, discussed how real-world data will improve the understanding of patients with cancer being treated at Miami Cancer Institute and of how the business runs overall.

Christopher Melani, MD, discusses the unmet needs remaining in the mantle cell lymphoma space.

An investigational bivalent gB/pp65 immunotherapeutic vaccine candidate has been granted orphan drug designation by the FDA for the treatment of patients with glioblastoma.

The FDA has granted orphan drug designation to MB-106, for the treatment of patients with Waldenstrom macroglobulinemia. The agent is being investigated in a phase 1/2 clinical trial.

The FDA has granted accelerated approval to dabrafenib plus trametinib for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors who harbor a BRAF V600E mutation.